Implantable circulating lubrication system for joints

ABSTRACT

A lubrication device for lubricating a joint of a human or mammal patient, which is entirely implantable in a patient&#39;s body, comprises a reservoir for storing a lubricating fluid and a fluid connection for introducing the lubricating fluid into the joint when the device is implanted in the patient&#39;s body. Further, the fluid connection comprises a fluid connection device connecting the reservoir with the joint such that a lubricating fluid flow is established from the reservoir into the joint. The fluid connection comprises either an infusion needle adapted to be intermittently placed into the joint for injecting the lubricating fluid, or a tube adapted to be permanently placed into the joint for continuously injecting the lubricating fluid.

This application is the U.S. national phase of International ApplicationNo. PCT/SE2010/050825, filed 12 Jul. 2010, which designated the U.S. andclaims the benefit if U.S. Provisional Nos.: 61/229,730 filed 30 Jul.2009; 61/229,731 filed 30 Jul. 2009; 61/229,733 filed 30 Jul. 2009;61/229735 filed 30 Jul. 2009; 61/229,738filed 30 Jul. 2009; 61/229,739filed 30 Jul. 2009; 61/229,743 filed 30 Jul. 2009; 61/229,745 filed 30Jul. 2009; 61/229,746 filed 30 Jul. 2009; 61/229,747 filed 30 Jul. 2009;61/229,748 filed 30 Jul. 2009; 61/229,751 filed 30 Jul. 2009; 61/229,752filed 30 Jul. 2009; 61/229,755, filed 30 Jul. 2009; 61/229,761 filed 30Jul 2009; 61/229,767 filed 30 Jul. 2009; 61/229,778 filed 30 Jul. 2009;61/229,786 filed 30 Jul. 2009; 61/229,789 filed 30 Jul. 2009; 61/229,796filed 30 Jul. 2009; 61/229,802 filed 30 Jul. 2009; 61/229,805 filed 30Jul. 2009; 61/229,811 filed 30 Jul. 2009; 61/229,815filed 30 Jul. 2009;61/229,816 filed 30 Jul. 2009; and which claims priority to SwedishApplication Nos.; 0900981-2 filed 10 Jul. 2009; 0900957-2 filed 10 Jul.2009; 0900958-0 filed 10 Jul. 2009; 0900959-8 filed 10 Jul. 2009;0900960-6 filed 10 Jul. 2009; 0900961-4 filed 10 Jul. 2009; 0900962-2filed 10 Jul. 2009; 0900963-0 filed 10Jul. 2009; 0900964-8 filed 10 Jul.2009; 0900965-5 filed 10 Jul. 2009; 0900966-3 filed 10 Jul. 2009;0900967-1 filed 10 Jul. 2009; 0900968-9 filed 10 Jul. 2009; 0900969-7filed 10 Jul. 2009; 0900970-5 filed 10 Jul. 2009; 0900971-3 filed 10Jul. 2009; 0900972-1 filed 10 Jul. 2009; 0900973-9 filed 10 Jul. 209;0900974-7 filed 10 Jul. 2009; 0900975-4 filed 10 Jul. 2009; 0900976-2filed 10 Jul. 2009; 0900977-0 filed 10Jul. 2009; 0900978-8 filed 10 Jul.2009; 0900979-6 filed 10 Jul. 2009; 090080-4 filed 10 Jul. 2009 andPCT/SE2009/000502 filed 24 Nov. 2009, the entire contents of each ofwhich are hereby incorporated by reference.

BACKGROUND

The present invention relates to an implantable lubrication device forlubricating a joint of a human or mammal patient, an implantablelubrication system and methods of treating a human or mammal patient bymeans of said implantable lubrication system.

The present invention is particularly suitable for long term orpermanent introduction of lubricating fluid in a joint, i.e. forintroduction of lubricating fluid on a permanent or periodical basisover long time intervals, e.g. over years.

The lubricating fluid (synovial fluid) reduces friction between thearticular cartilage and other tissues in a joint and lubricates andcushions the bone and tissue components of the joint during movement. Ifthe lubricating fluid is negatively affected and/or the joint articularcartilage usually covering the joint bone is damaged, in most cases dueto older age and/or continuing extensive or abnormal strain on human ormammal joints (e.g. knee joint, hip joint), this can result in adegenerative joint disease (also known as osteoarthritis) characterizedby a painful inflammation of the joint. Upon pathological reduction andchange of composition of the lubricating fluid within the joint space,which consists of the articulating surfaces of the adjacent bones withthe joint being stabilized and encompassed by the joint capsule and thesynovial membrane, the lubricating fluid can no longer perform its usualtask, i.e. lubrication of joint areas and shock absorption, togetherwith the articular cartilage.

If the articular cartilage is also severely damaged due toosteoarthritis or the like and/or the synovial fluid is reduced oraltered in its composition reducing its potential to lower frictionwithin the joint, the articulating surfaces are subjected to highfriction and increased wear causing a painful inflammation of the joint.This can result in serious restraints of movement, especially in walkingand standing, which further augment degenerative processes of the joint.Degenerative joint disease is highly prevalent in the western world,with this disease being one of the leading causes for chronic disabilityin Europe and the US.

Patients with osteoarthritis require a regular long term treatment bywhich lubricating fluid is introduced into the affected joint, which, onthe one hand, restores the physiological functionality of the damagedjoint as far as possible and, on the other hand, involves as littleextra stress as possible—both physical and psychological—for thepatient.

A known standard therapy is periodical extracorporeal injection ofsynthetic lubricating fluid into the joint space by a syringe in orderto substitute the absent physiological lubricating fluid. In suchconventional treatment it is inconvenient for the patient to deliver thelubricating fluid at regular time intervals through the skin and thejoint capsule into the joint by way of a syringe. Also, this may causeinjuries to the skin and the joint capsule, which increases the risk ofsevere infections of the delicate joint tissues. Therefore, an injectionmay not be performed more often than every half a year.

However, many patients need a replenishment of lubricating fluid moreoften, i.e. a continuous replenishment of small amounts of lubricatingfluid.

SUMMARY

An object is therefore to suggest an improved technique for lubricatinga damaged or worn out joint of a human or mammal patient that, on theone hand, sufficiently lubricates the joint and, on the other hand, hasa minimal infection risk.

The implantable lubrication device at least comprises, firstly, areservoir that stores a lubricating fluid and, secondly, a fluidconnection that introduces the stored lubricating fluid into the damagedjoint when the lubrication device is implanted in a patient's body. Thelubricating device can be completely implanted into the patient's bodysuch that a damaged joint can post-operatively be appropriatelylubricated from within the patient's body. This significantly reducesthe infection risk for the patient and permits a post-operative supplyof lubricating fluid to the damaged joint, continuously, intermittently,periodically or as required, e.g. depending on a fluid level within thejoint.

An implanted lubrication system according to the present inventioncomprises the implanted lubrication device and a lubricating fluidstored in its reservoir which is introduced into the joint by means ofits fluid connection.

Further compulsory or optional components of the implantable lubricationdevice, such as a reservoir, a pump or motor, an energy source, acontrol unit, may also be fully implemented within a patient's body.Such components may belong to the implantable infusion device or form anintegral part of the implantable lubrication system separate from theactual implantable infusion device. Since the implantable lubricationdevice is entirely implantable in the patient's body, i.e. the implantedlubrication system provides both a functionality for storing and afunctionality for transporting lubricating fluid within the patient'sbody, the complete flow path of the lubricating fluid for lubricatingthe joint lies within the patient's body. Hence, there is no longer aneed for extracorporeal injections into the joint.

The fluid connection comprises a fluid connection device that connectsthe reservoir of the implantable infusion device to the joint, thusestablishing a flow path for the lubricating fluid from the reservoirinto the joint. The fluid connection device is also fully implantableand preferably consists of a flexible tube or the like that is suitablefor post-operatively transporting the lubricating fluid stored in thereservoir to the joint.

Further, the fluid connection comprises an infusion member connected tothe fluid connection device. The infusion member may be introduced intothe patient's body in close relation to or inside the joint during asurgery, such that, post-operatively, the lubricating fluid can beintroduced into the joint. It may be arranged to intermittently injectlubricating fluid into the joint, e.g. periodically or if the fluidlevel falls below a predetermined threshold, e.g. upon actuation by adrive mechanism and dependent on sensor data. Alternatively andpreferably, the infusion member may also be arranged to continuouslyinject lubricating fluid into the joint, e.g. a predetermined amount oflubricating fluid per time unit, e.g. one drop per hour or the like.

An intermittent or periodical injection may be achieved e.g. by aninfusion needle that is placed in close relation to the joint during asurgery such that post-operatively it may be intermittently advancedinto the joint in the right position and retracted thereafter by a drivemechanism, thereby allowing intermittent lubrication of the jointthrough a tip end of the infusion needle. The drive mechanism isconfigured for advancing and retracting the tip end of the infusionneedle into and out of the joint. While the drive mechanism may beseparate from the infusion needle and/or the fluid connection device, itis nevertheless arranged as an integral part of the implantablelubrication device such that it is entirely implanted into the patient'sbody.

Alternatively, the infusion member may comprise an infusion tube that ispermanently placed in the joint in order to continuously introducelubricating fluid into the joint. In this case a separate drivemechanism for advancing/retracting an infusion needle is not needed,since the infusion tube may be of a reasonably soft material that doesnot, or not appreciably, disturb the normal operation of the joint.Therefore, the infusion tube may lie within the joint on a permanentbasis, such that lubricating fluid may be continuously inserted into thejoint space.

Preferably, the reservoir of the implantable lubrication devicecomprises a reservoir coupled to the fluid connection device for storingthe lubricating fluid. Typically the lubricating liquid is contained inthe reservoir. The reservoir may be arranged as a separate part of theimplantable lubrication device, which has to be separately implanted inthe patient's body. In order to establish a proper fluid flow oflubricating fluid into the joint, the reservoir may be adapted to changeits volume for creating an adequate pressure within the fluid connectiondevice and the infusion member to transport the lubricating fluid intothe joint.

Therefore, at least a portion of a periphery of the reservoir maycomprise a flexible outer wall for changing the volume of the reservoirby deformation of the flexible material as the lubricating fluid isfilled into or drawn out of the reservoir and for causing a fluid flowfrom the reservoir to the joint through the fluid connection device.

Thus, the reservoir may be of balloon type. The flexible material maycomprise a polymer membrane. A bellows construction is preferable havingpre-bent creases to reduce long term degradation. Drawing liquid fromthe reservoir into the fluid connection device and to the joint maycause a pressure decrease in at least part of the reservoir so that anegative pressure is attained as compared to the pressure in front ofthe infusion needle or the infusion tube at the joint end of the fluidconnection device. For instance, the reservoir may comprise a gaschamber and a liquid chamber, said chambers being separated by amembrane, e.g. the polymer membrane, and act as a spring for changingthe volume of the reservoir, such that the pressure in the gas chamberwill decrease when lubricating liquid is drawn from the liquid chamberinto the fluid connection device.

The reservoir may also have a refill injection port for refillinglubricating liquid from outside the human body into the implantedreservoir. The reservoir implanted in the patient's body along with thefluid connecting device may thus be kept small since the reservoir canbe refilled easily at appropriate time intervals. Preferably, theinjection port comprises a self-sealing material in respect ofpenetrations caused by a replenishing syringe that would be typicallyused to refill the reservoir through the patient's skin. It ispreferable to implant the reservoir of the lubrication device, or atleast the self-sealing injection port of the reservoir, subcutaneouslyin the patient's body so that it is easily accessible for refill bymeans of the syringe.

While the reservoir may be compressed manually in order to introducelubricating fluid through the fluid connection device and the infusionneedle or infusion tube into the patient's joint, it is preferred toconnect a pump to said fluid connection device and couple it between thereservoir and the infusion member for pumping the lubricating fluid fromthe reservoir into the joint. By means of the pump, it is easy tomeasure out an exact dose of the lubricating fluid and thereby supply anappropriate amount of lubricating fluid into the joint in a continuousor intermittent way.

The implantable pump preferably comprises a valve device having a firstand a second valve member, each of the said first and second valvemembers having a smooth surface facing each other so as to form asealing contact between the first and second valve members and furtherhaving different liquid channels that can be brought into alignment bydisplacement of the two smooth surfaces relative to one another whilemaintaining the sealing contact. This type of pump is described in greatdetail in WO 2004/012806 A1. The first and second valve members arepreferably made from a ceramic material for its excellent sealingcapabilities over a long period of time and its inertness to manysubstances. The pump may be a membrane type pump, as also described inWO 2004/012806 A1, but is not restricted to this type of pump. Themembrane type pump may comprise a membrane displaceable by a piston asthe piston moves, the piston being coupled to the valve device so as toslidably displace the first and second valve members relative to oneanother as the piston moves.

Preferably, manual actuation of either the pump or the drive mechanismsimultaneously causes actuation of the other, i.e. the drive mechanismor the pump. For instance, the pressure built up by the pump may causethe drive mechanism to advance the infusion needle and when the infusionliquid has been delivered through the tip end of the needle into thepatient's body, the pressure relief in the pump will allow a returnspring or other resilient means to retract the infusion needle.

The implanted pump may be actuated by mechanical remote control, by apressure sensitive switch arranged so as to be manually operable whenimplanted subcutaneously in the patient's body, or by a sensor mechanismthat measures the fluid level in the joint and actuates the pump (andthe drive mechanism for advancement and/or retraction of the infusionneedle) and actuates the pump if the measured fluid level falls below apredetermined threshold. Preferably, actuation of either the pump or thedrive mechanism simultaneously causes actuation of the other, i.e. thedrive mechanism or the pump. For instance, the pressure built up by thepump may cause the drive mechanism to advance the infusion needle andwhen the lubricating liquid has been delivered through the tip end ofthe infusion needle into the patient's body, the pressure relief in thepump will allow a return spring or other resilient means to retract theinfusion needle.

For actuating the pump and, if utilized, a drive mechanism for advancingand/or retracting an infusion needle into/out of the joint, and fordirectly or indirectly causing a lubricating fluid flow into the jointwithin said lubrication device, at least one motor may be provided. Themotor may be arranged e.g. for electrically, magnetically orelectromagnetically actuating the pump and/or drive mechanism or forhydraulically actuating the pump and/or drive mechanism. Preferably, themotor is arranged for actuating either the pump or the drive mechanism,thereby causing simultaneous actuation of the other, i.e. the drivemechanism or the pump. A motor may also be provided for actuation of anyother energy consuming part of the infusion device.

The term “motor” in the sense of the present invention includes anythingthat employs energy other than manual power and either automaticallytransforms such energy into kinetic or hydraulic or another type ofenergy or directly uses such energy to activate the pump, drivemechanism and/or other parts of the implanted lubricating device. Assuch, it is possible that part of the drive mechanism also forms a partof the motor, e.g. in the case of an electromagnetically actuated drivemechanism.

The motor forms part of the lubricating device and is implanted withinthe patient's body either separate from the body of the lubricatingdevice for remote implantation within the patient's body or contained inthe body of the lubrication device. Coupling elements may be providedeither for conductive or for wireless energy transfer from outside thedevice to the motor. For instance, the motor may be arranged for beingwirelessly driven by an external electromagnetic field. It is alsopossible to use an external energy source for use outside the patient'sbody, such as a primary energy source or a battery, in particular arechargeable battery, that is mounted on the patient's skin to provideenergy to the pump and/or drive mechanism and/or any other energyconsuming part of the lubrication device. The energy source may inparticular be connected to the at least one motor for actuating thesecomponents. An external energy source for wireless energy transfer maybe adapted to create an external field, such as an electromagneticfield, magnetic field or electric field, or create a wave signal, suchas an electromagnetic wave or sound wave signal.

Where the energy is wirelessly transferred to the implanted lubricationdevice, a transforming device for transforming the wirelesslytransferred energy into electric energy may be provided. Suchtransforming device is preferably adapted to be placed directly underthe patient's skin so as to minimize the distance and the amount oftissue between the transforming device and the energy supply meansoutside the patient's body.

An energy transmission device for wireless energy transfer from theenergy source and/or energy storage means to the transforming device maybe adapted to generate an electromagnetic field. Alternatively or inaddition, the energy transmission device for wireless energy transfermay be adapted to generate a magnetic field. Also, the energytransmission device for wireless energy transfer may be adapted togenerate an electric field. The wireless energy may also be transmittedby the energy transmission device by at least one wave signal. Suchsignal may comprise an electromagnetic wave signal, including at leastone of an infrared light signal, a visible light signal, an ultravioletlight signal, a laser signal, a microwave signal, a radio wave signal,an X-ray radiation signal and a γ-radiation signal. Also, the wavesignal may comprise a sound or ultrasound wave signal. Furthermore, thewireless energy may be transmitted as a digital or analog signal or acombination thereof.

Instead of or in addition to an external energy source, the implantablelubrication device may itself be provided with an energy source. Suchenergy source may be part of or may be contained within the body of thelubricating device. However, it may also be provided separate from thebody of the lubricating device for remote implantation within thepatient's body.

Such implantable energy source preferably comprises energy storagemeans, such as a long-life battery or, more preferably, an accumulator.The accumulator has the advantage of being rechargeable. Preferably, theaccumulator comprises a rechargeable battery and/or a capacitor.

Again, coupling elements for conductive or wireless energy transfer froma primary energy source outside the device to the accumulator may beprovided for charging the accumulator from outside the patient's bodywhen the device is implanted in the patient's body. Similarly, theaccumulator may comprise coupling elements for conductive and/orwireless energy supply to the at least one motor of the infusion device.

While the at least one motor may be provided with actuating means formanual activation of the motor, it is preferred to also provide acontrol unit for controlling the at least one motor. The control unitmay also be used to control the pump, drive mechanism and/or any otherenergy consuming part of the implanted lubricating device and, where thedevice includes an internal or external energy source, may even be usedto control such energy source. The control unit may be adjusted to thepatient's individual needs, such that the appropriate amount of medicinewill be administered at appropriate time intervals. Automaticadministration will substantially relieve the patient.

Preferably, the control unit has a data transfer port for data transferbetween an external data processing device outside the patient's bodyand the control unit implanted in the patient's body, regardless ofwhether the control unit is contained in the body of the lubricationdevice or whether it is implanted within the patient's body remote fromthe body of the lubricating device. Said data transfer port allows forsupervising the control unit to adapt the infusion device to changingneeds of the patient. Preferably, the data transfer port is a wirelesstransfer port for the data transfer, so as to provide easy data exchangebetween the control unit and the data processing device, e.g. during avisit at the doctor's. Most preferably, the control unit is programmableto further increase its adaptation flexibility.

The control unit—with or without the data transfer port—may also beprovided extracorporeally, e.g. mounted on the patient's skin. Anexternal control unit has the advantage of being easily accessible incase of any failure. It is preferably adapted for wireless remotecontrol of the at least one motor implanted with the infusion device.

A control signal transmission device may be provided for wirelesstransmission of an extracorporeal control signal to an implanted motor.Similarly, a data transmission interface for wirelessly transmittingdata from outside the patient's body to a control unit implanted insidethe patient's body may be provided. Again, the wireless control signaland/or data transmission may comprise one of the aforementioned wavesignals, being digital or analog or a combination thereof. Morepreferably, the control signal may be transmitted in the same manner asthe energy is transmitted to the motor. For instance, the control signalmay be transmitted by modulation of the energy signal, the energy signalthereby serving as a carrier wave signal for the digital or analogcontrol signal. More particularly, the control signal may be afrequency, phase and/or amplitude modulated signal.

Apart from or as a part of the control unit, feedback may be provided onparameters relevant for the treatment of the patient. Such parametersmay be either physical parameters of the patient and/or processparameters of the device. For that purpose, at least one feedback sensoris provided for detecting such parameters. For instance, the feedbacksensor may detect the level of lubricating fluid within the joint orother parameters relating to the condition of the joint and itslubrication. The feedback sensors may be connected to the control unitand the control unit may comprise a control program for controllingdelivery of lubricating fluid to the joint in response to one or moresignals of the feedback sensors. In addition or alternatively, feedbackdata may be transferred from the control unit to the external dataprocessing device. Such feedback data may be useful for the doctor'sdiagnosis.

Preferably, the fluid connection device consists of two fluid connectionportions each being connected to the reservoir and having an infusionmember at its open end to be inserted into the joint space. The twofluid connection portions may be arranged within the patient's body suchthat, post-operatively, they form a circular flow path for thelubricating fluid via the joint, i.e. from the pump and/or reservoir tothe joint (via a first fluid connection portion) and back to the pumpand/or reservoir (via a second fluid connection portion). Under thepressure created by a pump or a flexible outer wall of a reservoir thelubricating fluid may circulate intermittently or continuously throughthe circular flow path, the second fluid connection portion picking upthe lubricating fluid in the joint space that has been insertedthereinto via the first fluid connection portion.

Since due to the circular flow path the lubricating fluid is at leastpartly re-used after passing the joint, the fluid is soiled in thecourse of time by impurities or other foreign particles which may reducethe quality and desired effects of the lubricating fluid. The circularfluid connection device of the implantable lubrication device,therefore, may also comprise a filtering device having a filterconnected into the circular flow path to remove impure particles fromthe soiled circulating lubricating fluid. Preferably, the filteringdevice is adapted to regularly clean the filter and to remove theparticles filtered out of the lubricating fluid. These removedimpurities or foreign particles may then be deposited into a sealeddeposition space or may be given back to the patient's body, e.g. to thesurrounding tissue or into a blood vessel or the like.

The lubricating device may be implanted in the patient's body at variouslocations, preferably as near as possible to the damaged joint to belubricated. For instance, implantation of the lubrication device—or apart thereof—in the thigh for lubricating the femur ball or knee jointis possible. When the lubricating device or, e.g., its reservoir isrelatively voluminous, it may be preferable to implant the lubricatingdevice with a completely filled reservoir as it might be difficult torefill the reservoir in the abdomen. However, a subcutaneouslypositioned refill injection port connected via a tube to the reservoirmay be suitable in this case. Alternatively, the lubrication device mayalso be implanted subcutaneously. Subcutaneous implantation increasesthe possibilities of wireless energy and/or data transfer to/from thelubricating device, if desired. Also, refilling the reservoir through arefill injection port by means of a replenishing needle penetratingthrough the patient's skin is substantially facilitated when thelubricating device is implanted subcutaneously. Depending on theindividual treatment, it may be advantageous to implant the lubricatingdevice within fat tissue or intramuscularly or adjacent a joint so thatthe lubricating fluid can be injected into the particular joint.

Apart from the lubrication device with its various components describedabove, an implanted lubrication system according to the presentinvention comprises an appropriate lubricating fluid that is adapted tobe stored in the reservoir and to be introduced into the joint by theimplanted fluid connection. Preferably, the lubricating fluid isresorbable and bio-compatible in order to ensure resorption of andbiological and chemical interaction with the synthetic lubricating fluidby the patient's body in the same way as with a physiologicallubricating fluid. Preferably, the lubricating fluid is a hyaluronicacid or the like.

In one embodiment the implantable medical device is adapted to lubricateat least one artificial contacting surface carrying weight in a joint,when implanted in said human or mammal body, said artificial contactingsurface replacing at least the surface of at least one of a mammal'sjoint at least two contacting surfaces, said medical device furthercomprising, at least one outlet adapted to receive lubricating fluidfrom said a reservoir, and wherein

said medical device is adapted to be operable by an artificial operationdevice to distribute lubricated fluid from said reservoir and transportit to said at least one artificial contacting surface.

The implantable medical device may have said reservoir and the jointspaced apart, comprising a conduit for fluid connection between saidreservoir and the joint.

The implantable medical device may have the reservoir adapted to beplaced subcutaneously or in a cavity in the body in a region of thepatient selected from a group of regions consisting of:

-   a. the abdominal region,-   b. the inguinal region,-   c. the pelvic region, and-   d. the thigh region.

The implantable medical device may thus be placed in the abdomen.

The refill injection port may be adapted to be implanted subcutaneouslyor in connection with bone.

The implantable medical device may be adapted to lubricate oneartificial contacting surface and an opposite contacting surface of thehip or knee joint of a human or mammal patient.

The knee joint having a medial and lateral contacting weight carryingsurface, wherein said implantable medical device may be adapted tolubricate said artificial contacting surface on the medial side of theknee joint of a human or mammal patient.

The knee joint having a medial and lateral contacting weight carryingsurface, wherein said implantable medical device may be adapted tolubricate said artificial contacting surface of the lateral side on theknee joint of a human or mammal patient.

A mammal joint having at least two contacting surfaces. The medicaldevice is adapted to lubricate at least one artificial contactingsurface which has replaced at least the surface of at least one of themammal's joint contacting surfaces in said joint. Furthermore themedical device comprises at least one inlet adapted to receive alubricating fluid from a reservoir.

Normally at least one channel is at least partly integrated in theartificial contacting surface in connection with the at least one inletfor distributing the lubricating fluid to the surface of the artificialcontacting surface. The medical device could be adapted to be operableby an operation device to distribute lubricated fluid from a reservoir.The possibility to inject a lubricating fluid intermittently or whenneeded reduces the friction in the joint and enables an optimal level oflubrication in the joint.

According to one embodiment of the implantable medical device, it couldbe adapted to distribute the lubricating fluid to the surface of theartificial contacting surface on two or more portions of the artificialcontacting surface for lubricating the artificial contacting surface.The distribution in more than one portion could enable a more evendistribution of the lubricating fluid.

According to another embodiment the medical device the reservoir adaptedto hold the lubricating fluid could be an implantable reservoir placedin a cavity of the body, subcutaneously or in connection with bone.

The implantable medical device could further comprise an operationdevice adapted to transport a lubricating fluid from said reservoir tothe artificial contacting surface for lubricating the artificialcontacting surface.

According to one embodiment a reservoir could be adapted to hold thelubricating fluid and the operation device according to any of theembodiments herein could be adapted to transport the lubricating fluidfrom the reservoir to the artificial contacting surface for lubricatingthe artificial contacting surface. The operation device could be poweredand could comprise a pump adapted to pump fluid from the reservoir tothe artificial contacting surface for lubricating the artificialcontacting surface.

The operation device, according to any of the embodiments herein couldcomprise a reservoir, pre-loaded with pressurized lubrication fluid.

According to another embodiment, the implantable medical device couldfurther comprise an implantable injection port adapted to allow, byinjection into the injection port, to pre-load the reservoir withpressurized lubricating fluid.

The implantable medical device could, according to one embodiment,further comprise a valve adapted to close the connection between thereservoir and the artificial contacting surface. The reservoir could beadapted to be placed in a unit separate from the artificial contactingsurface and adapted to be connected to the artificial contacting surfacewith a conduit. The reservoir could comprise a moveable wall portionadapted to move and change the volume of the reservoir, the wall portioncould be a powered wall portion which could comprise a motor.

According to another embodiment, the implantable medical device couldcomprise at least one outlet and at least one further channel at leastpartly integrated in the artificial contacting surface. The medicaldevice could be adapted to allow circulation of a lubricating fluid; outfrom the artificial contacting surface through the outlet and in to theartificial contacting surface through the inlet. The circling of thefluid could be performed by means of an operation device adapted tocirculate the lubricating fluid. The circling system could comprise areservoir adapted to add fluid to the circulating lubricating fluid,and/or a filter to clean the circulating lubricating fluid.

The operation device according to any of the embodiments could beadapted to intermittently transport a lubricating fluid to theartificial contacting surface.

The implantable medical device could according to one embodimentcomprise a sensor adapted to sense a physical parameter inside thejoint, or a pressure or volume of the lubricating fluid, or a functionalparameter of the operation device to control the operation device toadjust the flow of lubricating fluid to the artificial contactingsurface.

The reservoir according to any of the embodiments could be connected tothe artificial contacting surface through a conduit. The inlet couldcomprise a connection part, for connecting the conduit to any part ofthe medical device. The conduit, according to any of the embodimentscould comprise a plurality of portions, which could be adapted to beconnected to each other through an inter-connecting part. A firstportion of the conduit could be in connection with the medical device,and the second portion of the conduit could be in connection with thereservoir. The conduit could according to one embodiment be adapted topass through a bone of the body for long-term keeping a passage way openthrough the bone, allowing the lubricating fluid to reach the artificialcontacting surface. According to another embodiment the conduit isadapted to pass through a joint capsule of the body for long-termkeeping a passage way open through the joint capsule, allowing thelubricating fluid to reach the artificial contacting surface andaccording to yet another embodiment the conduit is adapted to passthrough the pelvic bone from the opposite said of the acetabulum andinto the hip joint.

The implantable medical device could be adapted to lubricate a hip jointof a patient, in which case the artificial contacting surface of themedical device could be adapted to at least partly replace a contactingsurface of the Acetabulum, and/or the Caput femur.

The implantable medical device could according to one embodimentlubricate a second artificial contacting surface. According to oneembodiment the first artificial contacting surface comprises a convexshape towards a centre of the hip joint and the second artificialcontacting surface comprises a concave shape towards the centre of thehip joint. The first artificial contacting surface is according to thisopposite embodiment adapted to be fixated to the pelvic bone of thehuman patient, and the second artificial contacting surface is adaptedto be fixated to the femoral bone of the human patient. The artificialcontacting surface could be adapted to be introduced into the hip jointthrough a hole in the pelvic bone, from the abdominal side of the pelvicbone, an operational method which allows the hip joint capsule to bekept intact.

The reservoir could according to one embodiment be adapted to be placedinside, or at least partly inside of a bone of the patient, the bonecould for example be the femoral bone, the pelvic bone or the collumfemur of the patient.

According to another embodiment, the reservoir could be adapted to beplaced subcutaneously or in a cavity in the body, which could be acavity in a region selected from a group of regions consisting of: theabdominal region, the inguinal region, the pelvic region, and the thighregion.

The implantable medical device could according to one embodimentcomprise an injection port for filling of the reservoir. The injectionport could comprise a self sealing membrane, which for example could bea Parylene coated silicone membrane. The injection port could be adaptedto be implanted subcutaneously, in connection with bone or in a cavityof the body.

The reservoir could be adapted to place the lubrication fluid underpressure. For achieving the pressure the reservoir could be adapted tobe spring loaded, comprise a chamber adapted to hold a compressed gas orcomprise an elastic wall adapted to create the pressure. According toone embodiment the reservoir comprises a Parylene coated siliconeelastic wall.

According to another embodiment, the implantable medical device isadapted to lubricate a knee joint of a patient. The artificialcontacting surface to be lubricated could according to one embodiment beadapted to at least partly replace a contacting surface of the femoralbone, which could be a contacting surface of the Tibia bone and/or thefemoral bone.

According to one embodiment the medical device is adapted to lubricateat least one of the medial or lateral part of the contacting surface oftibia of the knee joint and according to another embodiment theimplantable medical device is adapted to lubricate at least one of themedial or lateral part of the contacting surface of the femoral bone ofthe knee joint. In yet another embodiment the medical device is adaptedto lubricate both the contacting surface of the femoral bone of the kneejoint and the contacting surface of the tibia bone of the knee joint.

According to one embodiment the reservoir according to any of theembodiments is adapted to be refilled from outside of the human body,the refilling could be performed through an implantable injection port.

According to one embodiment, the reservoir is adapted to hold apressure, which is possible to increase through injection of alubricating fluid through the injection port.

The implantable medical device according to any of the embodiments couldbe adapted to be a part of a system, which further could comprise atleast one switch implantable in the patient for manually andnon-invasively controlling the implantable medical device. The energizedsystem enables an operation device to operate the lubrication performedby the medical device.

The system could according to one embodiment further comprise ahydraulic device having an implantable hydraulic reservoir, which couldbe hydraulically connected to the implantable medical device. Theimplantable medical device could be adapted to be non-invasivelyregulated by manually pressing the hydraulic reservoir.

According to another embodiment, the system could further comprise awireless remote control for non-invasively controlling the implantablemedical device. The wireless remote control could comprise at least oneexternal signal transmitter and/or receiver, further comprising aninternal signal receiver and/or transmitter implantable in the patientfor receiving signals transmitted by the external signal transmitter ortransmitting signals to the external signal receiver. The wirelessremote control could further be adapted to transmit at least onewireless control signal for controlling the implantable medical device.The wireless control signal could comprise a frequency, amplitude, orphase modulated signal or a combination thereof. The wireless remotecontrol could further be adapted to transmit an electromagnetic carrierwave signal for carrying the control signal.

According to another embodiment the system could comprise a wirelessenergy-transmission device for non-invasively energizing the implantableenergy consuming components of the implantable medical device withwireless energy. The wireless energy could comprise a wave signal,selected from the following: a sound wave signal, an ultrasound wavesignal, an electromagnetic wave signal, an infrared light signal, avisible light signal, an ultra violet light signal, a laser lightsignal, a micro wave signal, a radio wave signal, an x-ray radiationsignal, gamma radiation signal, an electric field, a magnetic field, acombined electric and magnetic field.

A control signal in the system could comprise an electric field, amagnetic field, a combined electric and magnetic field. The signal couldcomprise an analogue signal, a digital signal, or a combination of ananalogue and digital signal. For powering the energy consumingcomponents of the implantable medical device, the implantable systemcould comprise an implantable internal energy source. According toanother embodiment the system comprises an external energy source fortransferring energy in a wireless mode, wherein the internal energysource is chargeable by the energy transferred in the wireless mode.

According to a further embodiment the system could further comprise asensor or a measuring device sensing or measuring a functional parametercorrelated to the transfer of energy for charging the internal energysource, and a feedback device for sending feedback information frominside the patient's body to the outside thereof, the feedbackinformation could be related to the functional parameter sensed by thesensor or measured by the measuring device.

According to yet another embodiment, the system could further comprise afeedback device for sending feedback information from inside thepatient's body to the outside thereof, the feedback information beingrelated to at least one of a physical parameter of the patient and afunctional parameter related to the implantable medical device.

The system could according to one embodiment further comprise a sensorand/or a measuring device and an implantable internal control unit forcontrolling the implantable medical device in response to informationbeing related to at least one of a physical parameter of the patientsensed by the sensor or measured by the measuring device and afunctional parameter related to the implantable medical device sensed bythe sensor or measured by the measuring device. The physical parametercould according to one embodiment be a pressure or a motility movement.

The system could according to one embodiment comprise an external datacommunicator and an implantable internal data communicator communicatingwith the external data communicator, the internal communicator feedsdata related to the implantable medical device or the patient to theexternal data communicator and/or the external data communicator feedsdata to the internal data communicator.

The system according to any of the embodiments herein, could furthercomprise a motor or a pump for operating the implantable medical device,or a hydraulic operation device for operating the implantable medicaldevice. The operation device could comprise a servo designed to decreasethe force needed for the operation device to operate the implantablemedical device instead the operation device acting a longer way,increasing the time for a determined action.

According to one embodiment the system could further comprise anoperation device for operating the implantable medical device. Thewireless energy could be used in its wireless state to directly powerthe operation device to create kinetic energy for the operation of theimplantable medical device, as the wireless energy is being transmittedby the energy-transmission device. The system could also comprise anenergy-transforming device for transforming the wireless energytransmitted by the energy-transmission device from a first form into asecond form energy.

The energy-transforming device could be adapted to directly powerimplantable energy consuming components of the implantable medicaldevice with the second form energy, as the energy-transforming devicetransforms the first form energy transmitted by the energy-transmissiondevice into the second form energy. The second form energy couldcomprise at least one of a direct current, pulsating direct current andan alternating current. The energy of the first or second form couldcomprise at least one of magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy thermal energy, non-magnetic energy, non-kinetic energy,non-chemical energy, non-sonic energy, non-nuclear energy andnon-thermal energy.

For protecting the system or the parts of the system, the system couldfurther comprise an implantable electrical component including at leastone voltage level guard and/or at least one constant current guard. Acontrol device could be arranged to control the transmission of wirelessenergy from the energy-transmission device, and an implantable internalenergy receiver for receiving the transmitted wireless energy, theinternal energy receiver could be connected to implantable energyconsuming components of the implantable medical device for directly orindirectly supplying received energy thereto, the system could furthercomprise a determination device adapted to determine an energy balancebetween the energy received by the internal energy receiver and theenergy used for the implantable energy consuming components of theimplantable medical device, the control device could be adapted tocontrol the transmission of wireless energy from the externalenergy-transmission device, based on the energy balance determined bythe determination device.

The determination device could be adapted to detect a change in theenergy balance, the control device could be adapted to control thetransmission of wireless energy based on the detected energy balancechange. The determination device could in turn be adapted to detect adifference between energy received by the internal energy receiver andenergy used for the implantable energy consuming components of theimplantable medical device, and the control device could be adapted tocontrol the transmission of wireless energy based on the detected energydifference.

The energy-transmission device could comprise a coil placed externallyto the human body, which in turn could further comprise an implantableenergy receiver to be placed internally in the human body and anelectric circuit connected to power the external coil with electricalpulses to transmit the wireless energy, the electrical pulses havingleading and trailing edges, the electric circuit adapted to vary firsttime intervals between successive leading and trailing edges and/orsecond time intervals between successive trailing and leading edges ofthe electrical pulses to vary the power of the transmitted wirelessenergy, the energy receiver receiving the transmitted wireless energyhaving a varied power. The electric circuit could be adapted to deliverthe electrical pulses to remain unchanged except varying the firstand/or second time intervals.

The system could according to one embodiment have an electric circuithaving a time constant which is adapted to vary the first and secondtime intervals only in the range of the first time constant, so thatwhen the lengths of the first and/or second time intervals are varied,the transmitted power over the coil is varied.

The implantable internal energy receiver for receiving wireless energycould comprise an internal first coil and a first electronic circuitconnected to the first coil, and an external energy transmitter fortransmitting wireless energy, the energy transmitter having an externalsecond coil and a second electronic circuit connected to the secondcoil, wherein the external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver, the system further comprising a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off.

The system could also comprise an implantable internal energy receiverfor receiving wireless energy, the energy receiver having an internalfirst coil and a first electronic circuit connected to the first coil,and an external energy transmitter for transmitting wireless energy, theenergy transmitter having an external second coil and a secondelectronic circuit connected to the second coil, wherein the externalsecond coil of the energy transmitter transmits wireless energy which isreceived by the first coil of the energy receiver, the system furthercomprising a feedback device for communicating out the amount of energyreceived in the first coil as a feedback information, and wherein thesecond electronic circuit includes a determination device for receivingthe feedback information and for comparing the amount of transferredenergy by the second coil with the feedback information related to theamount of energy received in the first coil to obtain the couplingfactors between the first and second coils.

In the embodiments in which the system comprises an external secondcoil, the external second coil could be adapted to be moved in relationto the internal first coil to establish the optimal placement of thesecond coil, in which the coupling factor is maximized. The externalsecond coil could also be adapted to calibrate the amount of transferredenergy to achieve the feedback information in the determination device,before the coupling factor is maximized.

According to a second aspect, a method of implanting the medical deviceaccording to any of the embodiments herein is further provided. Themethod comprises the steps of: creating an opening reaching from outsideof the human body into a joint, providing the artificial contactingsurface to the joint, fixating the artificial contacting surface to thejoint, implanting the reservoir in the human body, and lubricating theartificial contacting surface with use of a lubricating fluid containedin the reservoir.

The step of lubricating the joint contacting surface or the artificialcontacting surface with use of a lubricating fluid contained in thereservoir could comprise implanting an operation device adapted totransport the fluid from the reservoir to the artificial contactingsurface. According to another embodiment the step of lubricating theartificial contacting surface with use of a lubricating fluid containedin the reservoir comprises providing an energy source for powering theoperation device.

According to yet another embodiment the step of lubricating the jointcontacting surface or artificial contacting surface with use of alubricating fluid contained in the reservoir could comprise powering theoperation device using the energy source.

The step of implanting a reservoir in the human body could, according toone embodiment, comprise the step of implanting an operation devicebeing integrated in the reservoir, allowing the step of lubricating theartificial contacting surface with use of a lubricating fluid containedin the reservoir, using the operation device transporting the fluid fromthe reservoir to the artificial contacting surface.

Implanting the reservoir, according to any of the embodiments couldcomprise the step of implanting the reservoir at least partially insideof a bone of the patient, which could be the femoral bone of thepatient, the tibia bone of the patient and/or the pelvic bone of thepatient.

The step of providing the artificial contacting surface could comprisethe step of providing the artificial contacting surface from theabdominal side of the pelvic bone.

The step of implanting the reservoir in the human body could comprisethe step of implanting the reservoir subcutaneously. Placing thereservoir subcutaneously allows simple access to the reservoir andeliminates the need for a long conduit between an injection port and thereservoir.

The step of implanting the reservoir subcutaneously could comprise thestep of implanting the reservoir in at least one of the regions of thepatient selected from a group of regions consisting of: the abdominalregion, the inguinal region, the pelvic region, the thigh region, andthe calf region.

A further step of implanting an injection port for filling of thereservoir could be performed. The implantation of an injection portcould comprise the step of implanting the injection port in connectionwith bone.

According to one embodiment, the medical device comprises an artificialcontacting surface adapted to carry weight in a joint of a patient, theartificial contacting surface could comprise at least one channel fortransporting a lubricating fluid, the method comprises the steps of:implanting the medical device in a joint of the human patient,implanting a conduit adapted to be connected to the medical device,implanting an operation device for transporting a lubricating fluidinside the conduit, implanting a reservoir adapted to hold a lubricatingfluid, and at least postoperatively transporting, by the operationdevice, the lubricating fluid from the reservoir to the artificialcontacting surface in the conduit and further through the channel in theartificial contacting surface, thereby applying the lubricating fluid tothe artificial contacting surface.

Generally, the lubrication device may be implanted during a conventionalsurgery or by endoscopic or laparoscopic methods. Further, one has todifferentiate between methods for implanting a lubrication device havingan infusion needle for intermittent introduction of lubricating fluidand methods for implanting a lubrication device having an infusion tubefor continuous introduction of lubricating fluid.

In a method of treating a human or mammal joint, e.g. a human hip orknee joint osteoarthritis, by providing a lubricating fluid to the jointby means of the implantable lubrication device, a proper locationincluding an area of the joint is dissected free in the patient's bodyby surgery, which may especially include cutting the patient's skin anddissecting a suitable place for a reservoir to store the lubricatingfluid. Then, the lubrication device is placed at the dissected-freeproper location in such a way that the fluid connection maypost-operatively introduce lubricating fluid into the joint. For thispurpose, a hole is created in the joint capsule at the dissected-freearea of the joint and an infusion tube is introduced into the hole suchthat an open end of the infusion tube is placed in continuouscommunication with the joint in order to post-operatively injectlubricating fluid stored in the reservoir into the joint on a continuousbasis. That is, the infusion tube is inserted in the hole such that,firstly, the opening end of the infusion tube is kept in permanentcommunication with the joint to be lubricated and, secondly, theinfusion tube is in contact with the fluid connection device and thuswith the reservoir. After placement of the lubrication device, thepatient's body is closed such that the lubrication device is entirelyimplanted in the patient's body. This process may preferably beperformed in layers and by means of sutures or staples or adhesives orthe like. Finally, after the implantation process, the lubricating fluidis post-operatively introduced into the reservoir such that by operationof the implanted lubrication device the joint is adequately lubricated.

Alternatively, if the fluid connection comprises an intermittentlyoperating infusion needle as the infusion member, the placement of thelubrication device at the dissected-free proper location and the area ofthe joint is realized by placing the infusion needle in such a closerelation to the dissected area of the joint that a drive mechanism ofthe infusion needle may introduce and retract the infusion needleintermittently into/out of the joint such that lubricating fluid storedin the reservoir is intermittently injected into the joint. That is, theinfusion needle is placed in close relation to the dissected-free areaof the joint such that it may by intermittently introduced into thejoint for lubricating the joint and retracted thereafter by anappropriate drive mechanism connected to a drive mechanism or the like.

Another method of treating a human or mammal patient by means of theimplantable lubrication device utilizes endoscopic or laparoscopictechniques for creating an area of the joint via which lubricating fluidmay be injected into the joint by the infusion member. This area of thejoint is provided by, first, expanding a cavity in close relation to thejoint by inserting a needle-like or a tube-like instrument in thepatient's body and introducing a gas through the needle/tube-likeinstrument to fill gas into the tissue and thereby expand the cavitynear the joint. Thereafter, at least two laparoscopic/endoscopic trocarsare placed in the cavity and a camera and at least one dissecting toolare inserted through the laparoscopic trocars. The area of the joint isthen dissected with the inserted dissecting tool. Also, a properlocation for the remaining components of the lubrication device isdissected free, e.g. the reservoir, a pump or motor, or the like. Thelubrication device is then placed at the proper location, whereas thefluid connection with the infusion member is arranged at thelaparoscopically dissected area of the joint such that lubricating fluidis introduced into the joint. After placement of the lubrication device,the patient's body is closed with the effect that the lubrication deviceis entirely implanted in the patient's body. Thereafter, the lubricatingfluid can be post-operatively introduced into the reservoir such thatsaid joint is adequately lubricated through the fluid connection deviceand the infusion member.

Using the laparoscopic approach, again, a lubrication device havingeither an infusion tube or an infusion needle may be implanted. In theformer case, the reservoir is placed at the proper location and a holeis created in the joint capsule at the laparoscopically dissected areaof the joint and the infusion tube is inserted into the hole such thatthat an open end of the tube is placed in continuous communication withthe joint and the stored lubricating fluid may continuously be injectedinto the joint. In the latter case, after placing the reservoir at theproper location, an infusion needle and a drive mechanism are placed inclose relation to the laparoscopically dissected area of the joint suchthat the drive mechanism may intermittently introduce (and retract) theinfusion needle into (and out of) the joint in order to allow the storedlubricating fluid to be intermittently injected into the joint.

Closing the patient's body, or particularly the skin, may for instanceinclude suturing, taping and other suitable techniques. The lubricationdevice may be placed subcutaneously in the patient's body or within fattissue or intramuscularly. If appropriate, the lubrication device mayalso be placed within or adjacent the patient's gastro-intestinal orurinary tract. When it is placed adjacent the tract, it may be securedto the gastro-intestinal or urinary tract by means of a holder connectedto the lubrication device. As a further alternative, the lubricationdevice may be placed in the patient's thorax or in the patient'sabdomen. For instance, a reservoir may be placed in the abdomen orthorax cavity. Alternatively, the lubrication device or part thereof,such as a reservoir, may be implanted by open surgery, in which case thethorax or abdominal wall is opened for placing the lubrication device atthe proper location within the patient's thorax or abdomen and,afterwards, the skin and other layers of tissue are closed, such as bysuturing, being preferably sutured in layers. Replenishing of thereservoir preferably comprises the step of injecting a volume oflubrication liquid through the injection port connected to and/orintegrated in the periphery of the reservoir, e.g. a reservoir.

Functional hip movements are to be understood as movements of the hipthat at least partly correspond to the natural movements of the hip. Onsome occasions the natural movements of the hip joint might be somewhatlimited or altered after hip joint surgery, which makes the functionalhip movements of a hip joint with artificial surfaces somewhat differentthan the functional hip movements of a natural hip joint.

The functional position of an implantable medical hip device orprosthesis is the position in which the hip joint can perform functionalhip movements. The final position is to be understood as a functionalposition in which the medical device needs no further position change.

Functional knee movements are to be understood as movements of the kneethat at least partly correspond to the natural movements of the knee. Onsome occasions the natural movements of the knee joint might be somewhatlimited or altered after knee joint surgery, which makes the functionalknee movements of a knee joint with artificial surfaces somewhatdifferent than the functional knee movements of a natural knee joint.

The functional position of an implantable medical knee device orprosthesis is the position in which the knee joint can performfunctional knee movements.

Functional knee joint is a knee joint that can perform functional kneemovements either with or without an implanted medical device orprosthesis.

Full functional size is to be understood as the size of the medical kneedevice when said medical device is implanted in the knee joint.

Arthroscopy is to be understood as key hole surgery performed in ajoint, since the arthroscopic procedure could be performed in theabdomen of the patient some of the steps of this arthroscopic procedureis more laparoscopic, however for the purpose of this invention the twoterms arthroscopy and laparoscopy is used synonymously and for thepurpose of this invention the main purpose of these methods are is thatthey are minimally invasive.

The medical device according to any of the embodiments could comprise atleast one material selected from a group consisting of:polytetrafluoroethylene (PTFE), perfluoroalkoxy (PFA) and fluorinatedethylene propylene (FEP). It is furthermore conceivable that thematerial comprises a metal alloy, such as cobalt-chromium-molybdenum ortitanium or stainless steel, or polyethylene, such as cross-linkedpolyethylene or gas sterilized polyethylene. The use of ceramic materialis also conceivable, in the artificial contacting surfaces or the entiremedical device such as zirconium or zirconium dioxide ceramics oralumina ceramics. The part of the medical device in contact with humanbone for fixation of the medical device to human bone could comprise apoorhouse structure which could be a porous micro or nano-structureadapted to promote the growth-in of human bone in the medical device forfixating the medical device. The porous structure could be achieved byapplying a hydroxy-apatite (HA) coating, or a rough open-pored titaniumcoating, which could be produced by air plasma spraying, a combinationcomprising a rough open-pored titanium coating and a HA top layer isalso conceivable. The contacting parts could be made of a selflubricated material such as a waxy polymer, such as PTFE, PFA, FEP, PEor UHMWPE, or a powder metallurgy material which could be infused with alubricant, which preferably is a biocompatible lubricant such as aHyaluronic acid derivate. It is also conceivable that the material ofcontacting parts or surfaces of the medical device herein is adapted tobe constantly or intermittently lubricated. According to someembodiments the parts or portions of the medical device could comprise acombination of metal materials and/or carbon fibers and/or boron, acombination of metal and plastic materials, a combination of metal andcarbon based material, a combination of carbon and plastic basedmaterial, a combination of flexible and stiff materials, a combinationof elastic and less elastic materials, Corian or acrylic polymers.

Please note that any embodiment or part of embodiment as well as anymethod or part of method could be combined in any way. All examplesherein should be seen as part of the general description and thereforepossible to combine in any way in general terms. Please note that thedescription in general should be seen as describing both of an apparatusand a method.

The various aforementioned features of the embodiments may be combinedin any way if such combination is not clearly contradictory. Embodimentswill now be described in more detail in reference to the accompanyingdrawings. Again, individual features of the various embodiments may becombined or exchanged unless such combination or exchange is clearlycontradictory to the overall function of the device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a patient's body with an implanted lubrication device forlubrication of a hip joint and/or a knee joint;

FIGS. 1A and 1B illustrate the hip joint and the knee joint of FIG. 1,respectively, having an infusion member of the implanted lubricationdevice inserted therein;

FIG. 1C shows a lateral view of a knee joint when a medical device hasbeen provided.

FIG. 1D shows the medical device according to one embodiment, insection.

FIG. 1E illustrates the main components of an implanted lubricationdevice;

FIG. 1F shows a motor-driven implanted lubrication device establishing acircular flow path.

FIG. 2A shows an implanted lubrication device with an infusion needleand a drive mechanism.

FIG. 2B shows the lubrication device of FIG. 2A diagrammatically withsome modifications.

FIG. 2C shows a cross sectional view of a compact embodiment of theimplantable infusion device.

FIG. 2D shows a motor-driven pump unit suitable for use in connectionwith the embodiment shown in FIG. 1F.

FIG. 3 shows the medical device according to one embodiment comprisingan artificial contacting surface.

FIG. 4 shows the medical device according to one embodiment comprisingan artificial contacting surface, in section.

FIG. 5 shows a frontal view of a human patient displaying the hip joint.

FIG. 6 shows a lateral view of a human patient, in section, when alaparoscopic/arthroscopic procedure is being performed.

FIG. 7 shows the hip joint in section when a hole in the pelvic bone isbeing created.

FIG. 8 a shows the hip joint in section when a small hole in the pelvicbone is being created.

FIG. 8 b shows the hip joint in section when a medical device has beenprovided through a hole in the pelvic bone.

FIG. 9 a shows the hip joint in section when a medical device is beingprovided through a hole in the pelvic bone.

FIG. 9 b shows the hip joint in section when a medical device has beenprovided through a hole in the pelvic bone.

FIG. 10 shows the hip joint is section when a medical device connectedto an implantable lubrication system is being provided.

FIGS. 11 a-c show a surgical instrument for use in a method of providinga medical device according to any of the embodiments herein.

FIG. 12 shows the hip joint in section when a medical device has beenimplanted and connected to an implantable reservoir.

FIG. 13 a shows the lateral view of a hip joint ion section when a holeis being created through the femoral bone.

FIG. 13 b shows a hip joint in section when a medical device is beingprovided through a hole in the femoral bone.

FIG. 13 c shows a hip joint in section when a medical device has beenprovided through a hole in the femoral bone.

FIG. 13 d shows a reservoir adapted to be connected to a medical device,in further detail.

FIG. 14 shows the injection of a lubricating fluid into an implantableinjection port.

FIG. 15 shows an implantable medical device in an opposite embodiment.

FIG. 16 shows a hip joint in section, when an implantable medical devicein an opposite embodiment has been placed.

FIG. 17 shows a hip joint in section, when an implantable medical devicein an opposite embodiment has been placed.

FIG. 18 shows a hip joint in section, when an implantable medical devicein an opposite embodiment has been placed and connected to a reservoir.

FIG. 19 shows a frontal view of a knee joint of a human patient.

FIG. 20 shows a frontal view of a knee joint of a human patient, when amedical device has been provided.

FIG. 21 shows an implantable lubricating system.

FIG. 22 a shows a lateral view of a knee joint when a medical device hasbeen provided to the femoral bone.

FIG. 22 b shows a lateral view of a knee joint when a medical device hasbeen provided to the tibia bone.

FIG. 23 shows a medical device comprising an artificial knee jointsurface.

FIG. 24 shows a medical device comprising an artificial knee jointsurface in section.

FIG. 25 a shows a medical device comprising multiple medical deviceparts.

FIG. 25 b shows a medical device comprising multiple medical deviceparts, when assembled.

FIG. 26 shows the placing of a medical device comprising multiplemedical device parts, when being fixated to the tibia bone.

FIG. 27 shows the implantable medical device according to an embodiment,when fixated to the tibia bone and connected to a reservoir and aninjection port.

FIG. 28 shows a frontal view of a human patient when an implantablelubricating system has been provided.

FIG. 29 shows an implantable lubrication system in further detail.

FIG. 30 shows an implantable circling lubrication system in furtherdetail.

FIG. 31 shows an implantable circling lubrication system comprising afilter, in further detail.

FIG. 32 shows an implantable lubrication system, when lubricating anartificial hip joint surface.

FIG. 33 a shows an implantable lubrication system comprising aretractable needle, in a first state.

FIG. 33 b shows an implantable lubrication system comprising aretractable needle, in a second state.

FIG. 34 illustrates a system for treating a disease, wherein the systemincludes an apparatus of the invention implanted in a patient.

FIGS. 35-49 schematically show various embodiments of the system forwirelessly powering the apparatus shown in FIG. 34.

FIG. 50 is a schematic block diagram illustrating an arrangement forsupplying an accurate amount of energy used for the operation of theapparatus shown in FIG. 34.

FIG. 51 schematically shows an embodiment of the system, in which theapparatus is operated with wire bound energy.

FIG. 52 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the apparatus shown in FIG. 34.

FIG. 53 is a circuit for the arrangement shown in FIG. 52, according toa possible implementation example.

FIGS. 54-60 c show various ways of arranging hydraulic or pneumaticpowering of an apparatus implanted in a patient.

DETAILED DESCRIPTION

In the following a detailed description of preferred embodiments will begiven. In the drawing figures, like reference numerals designateidentical or corresponding elements throughout the several figures. Itwill be appreciated that these figures are for illustration only and arenot in any way restricting the scope. Thus, any references to direction,such as “up” or “down”, are only referring to the directions shown inthe figures. Also, any dimensions etc. shown in the figures are forillustration purposes.

Please note that any embodiment or part of embodiment as well as anymethod or part of method could be combined in any way. All examplesherein should be seen as part of the general description and thereforepossible to combine in any way in general terms.

FIG. 1 shows a patient's body with an implanted lubrication deviceconsisting of a main body 1401 and two fluid connection tubes 1402 thattransport a lubricating fluid stored in a reservoir into the joints tobe lubricated, here a hip joint and a knee joint. For this reason, themain body 1401 comprises a reservoir for storing the lubricating fluidand may also comprise further components, such as a pump, a motor, acontrol unit or the like. The lubrication device, i.e. all itscomponents, is fully implantable into the patient's body such that thejoint can be appropriately lubricated post-operatively independently ofany extracorporeal components or injections, which significantly reducesthe infection risk for the patient. Depending on the type of joint andon the severity of the damage to the joint, a joint may be lubricatedintermittently/periodically, continuously, or as required, e.g.depending on a lubricating fluid level within the joint. Generally, themain body 1401 of the lubrication device may be implanted subcutaneouslyso that it is easily accessible, e.g. for refilling the reservoir orsetting up functionalities or modes of operation via a wireless controlunit or the like.

In FIGS. 1A and 1B the two lubricated joints shown in FIG. 1, the hipjoint and the knee joint, are illustrated respectively in greaterdetail. In FIGS. 1A and 1B it can be seen that the fluid connection tube1402 has at its end an infusion member being inserted into the jointspace which finally brings the lubricating fluid into the joint. FIG. 1Ashows an infusion needle 1403 which is injected through the jointcapsule into the joint space of the hip joint. The infusion needle 1403may, in connection with a drive mechanism (not shown), be advanced intothe joint space and refracted from it in order to intermittentlylubricate the joint. Alternatively, in FIG. 1B, the infusion member isan infusion tube 1404 that is permanently placed in the joint space suchthat a continuous flow of lubricating fluid reaches the joint. Thematerial of the infusion tube 1404 may be a soft material not or onlyminimally disturbing the joint in its regular operation. A drivemechanism is not required for the infusion tube 1404 of FIG. 1B.

Generally, there are two basic methods for implanting the lubricationdevice, a conventional method in which an area of the joint is dissectedfree and the infusion needle 1403 or infusion tube 1404 is arranged atthe free-dissected area, and a laparoscopic method in which a cavity atthe joint is expanded laparoscopically and the infusion needle 1403 orinfusion tube 1404 is placed in the cavity through laparoscopic trocars.If the fluid connection tube 1402 ends in an infusion needle 1403, asshown in FIG. 1A, the infusion needle 1403 is placed in close relationto the joint capsule or into a hole in the capsule in such a way that adrive mechanism of the needle may introduce and retract the infusionneedle 1403 intermittently into and out of the joint space such thatlubricating fluid stored in the reservoir is intermittently injected.If, alternatively, the fluid connection tube 1402 ends in an infusiontube 1404, as shown in FIG. 1B, a permanent hole is created in the jointcapsule in which the tube is continuously placed such that thelubricating fluid may be continuously injected into the joint.

FIG. 1C shows a medical device according to an embodiment in which themedical device comprises a first artificial contacting surface 1101adapted to replace the distal surface of the femoral bone 102, beingpart of the knee joint. The first artificial contacting surface 1101could be adapted to replace the surface of the lateral condyle, themedial condyle or both the lateral and medial condyles. The medicaldevice of FIG. 1C further comprises a second artificial contactingsurface 1102 being adapted to replace the contacting surface of thetibia bone being the other contacting surface of the knee joint. Theimplantable medical device comprises an inlet 1104 adapted to receive alubricating fluid from a reservoir 1108, which according to thisembodiment is placed on the rear side of the tibia bone and the rearside of the femoral bone 102, respectively. The reservoir 1108 isaccording to this embodiment adapted to be refilled by means of aninjection port 1107 being placed in fluid contact with the reservoir1108. The reservoir 1108 supplies the inlet 1123 with a lubricatingfluid through a conduit 1106 which supplies a fluid connection betweenthe medical device and the reservoir 1108. The reservoir is according tothis embodiment adapted to be placed under pressure through saidinjection port 1108 comprising chamber for pressurized gas which isfurther compressed when the reservoir 1108 is being filled through theinjection port 1107. The inlet 1123 transports the lubricating fluid toa channel 1105 which is at least partly integrated in said artificialcontacting surfaces 1101, 1102. According to the embodiment of FIG. 1the channel 1105 is fully integrated in the medical device. The channel1105 distributes the lubricating fluid over the artificial contactingsurfaces 1101, 1102 and thereby lubricates the artificial contactingsurfaces 1101, 1102 and improves the function thereof by reducing thefriction. The implantable medical device could just as well be adaptedto be implanted in the knee joint of another mammal, such as a horse.

FIG. 1D shows the implantable medical device according to an embodimentwhere the medical device is adapted to replace parts of the hip joint.The medical device comprises a plurality of channels 1105 adapted tolubricate the artificial contacting surface of the hip joint by alubricating fluid being injected to the channel through a conduit 1106placed centrally in the implantable medical device. The conduit 1106places the plurality of channels 1105 in fluid connection with areservoir 1108 which is located in the stem part, adapted for fixationin the femoral bone of a human patient, of said medical device. Theconduit 1106 transports lubricating fluid to the inlet 1123 for furtherdistribution to the channels 1105. The reservoir 1108 according to theembodiment of FIG. 1D is spring loaded by a spring 1109 which pushes amovable wall portion in the shape of a piston 1110 for placing saidlubricating fluid under pressure. The reservoir 1108 is adapted to berefilled through the injection port 1107, which is placed on the lateralside of the medical device. The injecting of lubricating fluid throughthe injection port 1107 compresses the spring 1109 which thereby placesthe lubricating fluid under pressure, which pressure presses thelubricating fluid through the conduit 1106 and to the channels 1105 forlubricating the hip joint of a human patient. The spring loadedreservoir 1108 could be replaced by other types of reservoirs adapted toplace a pressure on the lubricating fluid, such as a reservoir 1108comprising a chamber filled with a pressurized gas which is furtherpressurized by the injecting of a lubricating fluid through an injectionport, it is furthermore conceivable that the reservoir 1108 is anelastic reservoir in which case the elastic properties of the elasticreservoir pressurized the lubricating fluid.

FIG. 1E illustrates an implanted lubrication device and its maincomponents. The lubrication device of FIG. 1E comprises a reservoir Rfor storing the lubricating fluid and a fluid connection tube 1402 thatconnects the reservoir R with an infusion tube placed with its open endpermanently within a joint space. In order to create an appropriatepressure for forcing the lubricating fluid from the reservoir R throughthe fluid connection tube 1402 and the injection tube 1404 into thejoint, a gas chamber 1407 is arranged within the reservoir R that mayproduce the required pressure upon expanding its volume. Further, thereservoir is subcutaneously implanted such that a refill injection port1406 arranged in the outer wall of the reservoir R is accessible throughthe patient's skin 1405 such that lubricating fluid can be replenishedinto the reservoir R by a syringe injected through the patient's skin1405. The refill injection port 1406 may thus be made of an appropriatemembrane, e.g. a polymer material, which is self-sealing with respect tothe penetration of an injection syringe.

FIG. 1F shows another embodiment of the lubrication device according tothe present invention. A pump P driven by a motor M connects a reservoirR with a circular fluid connection tube 1402 consisting of two tubeportions 1402 a, 1402 b that form a full circular flow path for thelubricating fluid via the reservoir R and the lubricated joint. Each ofthe two tube portions 1402 a, 1402 b comprises an individual infusiontube 1404 a, 1404 b inserted into the joint space, whereas thelubricating fluid stored in the reservoir is introduced into the jointspace via the tube portion 1402 a with the infusion tube 1404 a, whilethe used lubricating fluid is led from the joint back to the reservoirvia the tube portion 1402 b with the infusion tube 1404 b via a filterdevice 1427 with a filter 1428 placed within the flow path partiallydefined by tube portion 1402 b. Under the pressure created by the pump Pthe lubricating fluid is circulated continuously within the circularflow path formed by the fluid connection tube portions 1402 a, 1402 b,such that the lubricating fluid may be at least partly re-used afterpassing the joint. However, in order to enable re-usage of thelubricating fluid flowing out of the joint and into infusion tube 1404b, possible soiling and impurities or other foreign particles which havebeen added to the lubricating fluid on its way through the joint areremoved by the filtering device 1427 in order to secure the quality anddesired effects of the lubricating fluid upon re-usage. The filteringdevice 1427 has a filter 1428 which is placed within the flow path suchthat the complete lubricating fluid passes through the filter. Thefiltering device 1427 is adapted to regularly clean the filter 1428 byremoving the filtered particles from the filter 1428 and depositing themin a sealed deposition space 1433. Alternatively, the removed particlescan also be given back to the patient's body, e.g. into a blood vesselor the like.

Although the embodiment shown in FIG. 1F may comprise a great variety ofreservoir types, a particular reservoir type will be described below.The volume of reservoir R shown in FIG. 1F is divided into two sectionsby means of a membrane 1429. One section is filled with gas, whereas theother section is filled with lubricating fluid. A refill injection port1430 allows for refilling reservoir R with infusion liquid by means of areplenishing needle through the patient's skin 1405. When reservoir R isin its full state, the gas section is at ambient pressure orover-pressurized. As lubricating fluid is drawn from reservoir R uponeach lubrication cycle, the pressure in the gas section will decreasebelow ambient pressure, i.e. to a negative relative value. Dependingupon the particular type of pump P, it may be advantageous to provide anactive ball valve 1431 to prevent any back-flow from pump P to reservoirR and another active ball valve 1432 to prevent any back-flow from thereservoir R into the fluid connection conduit 1402 b.

Motor M is wirelessly controlled by a control unit C implanted in thepatient's body as well. However, it is also possible to place thecontrol unit C outside the patient's body and establish a wirelesscommunication between control unit C and motor M or provide galvaniccontacts through the patient's skin. Preferably, the control unit C isimplanted along with motor M, in which case control unit C is preferablyprogrammable from outside the patient's body, either wirelessly orthrough galvanic contacts, so as to allow proper configuration of thecontrol unit according to changing demands. Control unit C determinesthe time period between the infusion cycles as well as the amount oflubricating fluid to be injected into the space upon each infusioncycle. In addition to or instead of control unit C, a pressure sensitiveswitch for activating motor M may be arranged subcutaneously.

There are various ways of providing motor M with energy. For instance,energy may be supplied from outside the patient's body e.g. for chargingan accumulator A, such as a rechargeable battery and/or a capacitor. Inthe embodiment shown in FIG. 1F, an extracorporeal primary energy sourceE transmits energy of a first form through the patient's skin 1405 to anenergy transforming device T which transforms the energy of the firstform into energy of a second form, such as electric energy. The electricenergy is used to recharge accumulator A which provides secondary energyto motor M upon demand.

In general, external energy source E may be adapted to create anexternal field, such as an electromagnetic field, magnetic field orelectric field, or create a wave signal, such as an electromagnetic waveor sound wave signal. For instance, energy transforming device T asshown in FIG. 1F may act as a solar cell, but be adapted to theparticular type of wave signal of primary energy source E. Energytransforming device T may also be adapted to transform temperaturechanges into electric energy. Instead of an external primary energysource E, an implantable primary energy source E may be used, such as aregular long-life battery instead of accumulator A. The energy signalcan also be used to transmit a control signal of the control unit C byappropriate modulation of the energy signal, regardless of whether theenergy is transmitted wirelessly or by wire, the energy signal therebyserving as a carrier wave signal for the digital or analog controlsignal. More particularly, the control signal may be a frequency, phaseand/or amplitude modulated signal.

FIG. 2A shows in further detail an implanted lubrication devicecomprising an infusion needle 1403 having a tip end 1408. Tip end 1402is closed at its distal end and has a lateral lubricating fluid deliveryexit port 1409. Needle 1403 is arranged for longitudinal displacementwithin an open-ended fluid connection tube 1402 upon activation by adrive mechanism D.

The fluid connection tube 1402 is attached to an implanted pump P. PumpP is schematically shown and can be designed in many ways. In FIG. 2A,reservoir R holding the lubricating fluid to be injected into a patent'sjoint space is part of pump P. Alternatively, reservoir R could beseparate from pump P and connected thereto, e.g. as basically shown inFIG. 2B. In FIG. 2A, however, a movable or flexible wall 1410 of a pumpP, which may be realized as a piston or the like, is electrically (ormanually) displaceable so as to intermittently pump lubricating fluidfrom reservoir R through fluid connection tube 1402 towards infusionneedle 1403. The pump P could e.g. be motor-driven, and the motor couldbe automatically controlled so as to intermittently inject a certainamount of lubricating fluid at certain time intervals via the infusionneedle 1403 into the joint space. Reservoir R, pump P and/or othercomponents of the implanted lubrication device, such as theaforementioned motor, an automatic control for the motor, etc., arepreferably implanted along with infusion needle 1403 and drive mechanismD. Of course, other appropriate modifications are possible, as willbecome apparent upon further consideration of other embodiments of thepresent invention.

In the lubrication device shown in FIG. 2A, as the pressure is increasedin reservoir R by actuation of the movable/flexible wall 1410 this willresult in a displacement of infusion needle 1403 against the force of aspring 1411 of drive mechanism D. Thus, tip end 1408 of infusion needle1403 will penetrate into the joint space to be lubricated. When returnspring 1411 is completely compressed and the pressure exerted on thelubricating fluid by means of the moving/flexible wall 1410 is furtherincreased, a ball valve 1412 will be displaced against a second returnspring 1413 which is stronger than the first return spring 1411. Thatway, as long as the pressure is held at a sufficiently high level,lubricating fluid will be pumped from reservoir R through fluidconnection tube 1402, hollow infusion needle 1403 and the needle's exitport 1409 into the patient's joint space. Upon pressure release, ballvalve 1412 will close due to return springs 1411 and 1413, and theninfusion needle 1403 will be retracted to its initial position as shownin FIG. 2A. This process will be periodically repeated depending on thecondition and type of the joint to be lubricated such that anintermittent lubrication of the particular joint is achieved.

It should be noted that the force acting on infusion needle 1403 toadvance the same may be calculated as the product of the actual pressureand the cross section of needle 1403. Since the cross section of atypical infusion needle is relatively small, high pressure will have tobe exerted in order to penetrate into the joint space and to overcomethe counteracting forces of return springs 1411 and 1413. It istherefore advantageous to construct drive mechanism D such that twostrictly separated chambers are formed in front of and behind the drivemechanism. Thus, when the chamber behind drive mechanism D is kept atlow pressure, such as ambient pressure, the force acting on infusionneedle 1403 would correspond to the product of the actual pressure andthe entire cross section of drive mechanism D and, thus, besubstantially higher.

This is shown in FIG. 2B. Drive mechanism D comprises a piston 1414 towhich infusion needle 1403 is attached as shown in FIG. 3. Piston 1414separates a first chamber 1415 a in front of piston 1414 and a secondchamber 1415 b behind piston 1414. While the pressure in first chamber1415 a corresponds to the pressure exerted by pump P, the pressure insecond chamber 1415 b can be kept at a lower value. For instance,chamber 1415 b could be filled with a compressible gas. In that case,return spring 1411 could be dispensed with as the compressed air wouldalready create a needle retraction force.

It is difficult to securely seal a gas chamber, however. Therefore,second chamber 1415 b is instead filled with fluid, such as thelubricating fluid, and the liquid may be urged into a flexible volume1416. The flexible volume 1416 could be of simple balloon type so as tofill up without exerting any strong counterforce. Alternatively, theflexible volume 1416 may comprise a gas chamber separated from the fluidof second chamber 1415 b by a flexible membrane. Again, return spring1411 could be dispensed with in this case.

Instead of the flexible volume 1416, a conduit 1417 (acting as fluidconnection tube 1402) may connect second chamber 1415 b with reservoirR. Thus, when infusion needle 1403 is advanced, fluid will be expelledfrom second chamber 1415 b through conduit 1417 into reservoir R, and asinfusion needle 1403 is refracted by means of return spring 1411, fluidwill be drawn from reservoir R through conduit 1417 back into secondchamber 1415 b. Pump P and reservoir R are be implanted into thepatient's body along with drive mechanism D and needle 1403, eitherremote thereof or as a single unit, if desired.

FIG. 2C shows a very compact lubrication device to be implantedsubcutaneously and in close vicinity and in an appropriate relativeposition to the joint to be lubricated, such that the needle 1403 mayintermittently advance into the joint upon activation by the drivemechanism D. The individual components of the device are containedwithin a unitary body 1418 comprising an outer wall 1419 a, 1419 b. Thevolume defined by outer wall 1419 a, 1419 b is completely filled withlubricating fluid. A wall portion 1419 a is flexible so as to allow forvolume changes occurring with each injection and refill. Wall portion1419 a is made from a polymer material which is self-sealing withrespect to the penetration of an infusion needle 1403. The lubricationdevice can thus be refilled with lubricating fluid through the polymerwall portion 1419 a while being implanted subcutaneously.

The other wall portion 1419 b is rigid to provide some stability for theindividual components contained within body 1418. A window area 1420 isformed in rigid wall portion 1419 b and a penetration membrane 1421 issealingly press fitted in window area 1420. Penetration membrane 1421 ismade from a self-sealing material in respect of penetrations resultingfrom infusion needle 1403, which infusion needle is arranged forpenetrating window area 1420 and thereby penetrating into the jointspace to be lubricated.

Needle 1403 is connected to a piston 1414 separating a first chamber1415 a in front of piston 1414 and a second chamber 1415 b behind piston1414, as discussed above in reference to FIG. 2B. A return spring 1411and a ball valve 1412 with a return spring 1413 are also provided.Openings 1422 are provided to connect second chamber 1415 b to reservoirR so that when the pressure is raised in first chamber 1415 a piston1414 may expel lubricating fluid from second chamber 1415 b throughopenings 1422 into reservoir R, which reservoir R is approximately atambient pressure.

The pressure in first chamber 1415 a is increased by means of a pump Pcomprising a movable/flexible wall 1410 moved forth and back by anappropriate drive mechanism, motor or the like. A flow passage 1423 isformed in a housing 1424 in which piston 1410 is slidably arranged. Theflow passage has a flow constriction 1425 and an exit opening 1426within the housing 1424.

The infusion device shown in FIG. 2C functions as follows. When themovable/flexible wall 1410 is actuated (i.e. moved in the direction ofthe arrow), the lubricating fluid contained in first chamber 1415 a willnot flow back into reservoir R through flow passage 1423, due to flowconstriction 1425 in flow passage 1423, but will urge piston 1412 withneedle 1403 towards window area 1420 while expelling lubricating fluidfrom second chamber 1415 b through openings 1422 into reservoir R. Whenpiston 1412 is in its end position and the movable/flexible wall 1410 isfurther moved in arrow direction, the pressure in first chamber 1415 awill eventually rise to a level sufficiently high to overcome the springforce of return spring 1413, thereby opening ball valve 1412 andallowing lubricating fluid to be discharged through hollow needle 1403,the tip end 1408 of which has meanwhile penetrated membrane 1418 and thejoint at which the body 1418 of the lubrication device is appropriatelypositioned. Upon a release of the pressure in the first chamber 1415 adue to backward sliding of movable/flexible wall 1410, ball valve 1412will immediately close and piston 1412 with infusion needle 1403 will besimultaneously drawn back into its retracted position. The flow passage1423 is needed to allow movable/flexible wall 1410 to move furtherbackwardly even after piston 1412 has reached its starting position,thereby drawing additional lubricating fluid from reservoir R into firstchamber 1415 a, which additional lubricating fluid compensates theamount of lubrication liquid delivered to the patient during theintermittent injection cycles. In addition to the intermittent advancingand retracting capabilities of drive mechanism D, the drive mechanism ofthe lubrication device shown in FIG. 2C may further comprise means forlaterally displacing the tip end 1408 of infusion needle 1403 as toprevent fibrosis or the like.

The lubrication device shown in FIG. 2C provides several advantages suchas not involving any gas chambers and not requiring any particularsealing of movable/flexible wall 1410 and piston element 1414. It shouldbe noted that all components of the infusion device shown in FIG. 28 maybe made from polymer material, although it is preferable that at leastinfusion needle 1403 and return springs 1411, 1413 be made from an inertmetal.

FIG. 2D shows a cross-sectional view of a motor-pump unit that could beused in connection with the arrangement shown in FIG. 1F. Thismotor-pump unit is extensively described in WO 2004/012806 A1 and theother pump units disclosed therein may be employed in connection withthe present invention as well. The motor-pump unit comprises a valvepump assembly, wherein a membrane pump P and a valve pump device 1434constitute two main elements of the assembly mounted in a cylindricalhousing 1435. Valve device 1434 includes a first valve member in theform of a ceramic disc 1436 stationary mounted on and fixed to housing1435, and a second valve member in the form of a ceramic disc 1437facing and touching ceramic disc 1436 and rotatable relative tostationary disc 1436. A motor 1438 is mounted on housing 1435 enclosingceramic discs 1436 and 1437. Motor 1438 includes a splined motor shaftcoupled to corresponding splines in a lower central hole in rotatabledisc 1437 to allow disc 1437 to move somewhat in an axial directionrelative to motor shaft 1439, although disc 1437 follows the rotation ofmotor 1438. On motor shaft 1439 there are mounted a stop member 1440 anda spring washer 1441 that exerts a slight amount of pressure againstdisc 1437 to urge it against stationary disc 1436.

Pump P includes a pump membrane 1451 that can be any kind of membrane.Preferably, membrane 1451 is a metal membrane, for example a titaniummembrane, or a type of coated plastic material for achieving long lifeand avoiding diffusion of liquid through membrane 1451 over time. Anoperation device, which in this embodiment is incorporated in the valvepump assembly, includes a cam sleeve 1452 which has a cut-out groovewith two opposite cam surfaces 1453, a cam wheel 1454, which rotates inthe cut-out groove pushing against cam surfaces 1453, and a pump shaft1455 connected to rotary disc 1437. Cam wheel 1454 is mounted via a camwheel shaft 1456 onto pump shaft 1455. Pump shaft 1455 rotates becauseit is connected to rotating disc 1437 via a splined shaft 1461 that iscoupled to corresponding splines in an upper central hole 1461 inrotatable disc 1437. The described spline coupling allows disc 1437 tomove somewhat in an axial direction relative to pump shaft 1455. Pumpshaft 1455 is mounted in an encapsulated ball-bearing 1458 and isstationary in an axial direction with respect to ball-bearing 1458.Several elongated grooves 1459 on pump shaft 1455 extend pastball-bearing 1458 and serve as liquid flow passages between firstchannel 1442 of stationary disc 1436 and a pump chamber 1460 undermembrane 1451.

When motor 1438 is rotating, membrane 1451 moves up and down. Asmembrane 1451 moves up and down, rotatable disc 1437 connects firstchannel 1442 alternately to second and third channels 1444 and 1445 sothat liquid is either transmitted from second channel 1444 or thirdchannel 1445 to pump chamber 1460 or received from pump chamber 1456 bysecond channel 1444 or third channel 1445. In FIG. 2D, first channel1442 is shown as being connected to second channel via opened channel1450 so that second channel 1444 receives liquid through first channel1442 from chamber 1460.

The particular material selected for discs 1436 and 1437 is importantbecause the selected material must be able to function using very finetolerances without such discs sticking to one another over time. Thereare several materials available on the market that are suitable for thispurpose, e.g. ceramic or ceramic mixed with other materials, such ascarbon fiber.

FIG. 3 shows the medical device according to an embodiment in which themedical device is adapted to replace the contacting surface of the caputfemur of the femoral bone of a human patient. The medical deviceaccording to this embodiment the artificial contacting surface 1103 b ofthe medical device comprises a plurality of channels adapted tolubricate the hip joint of a human patient with a lubricating fluid. Themedical device further comprises a fixating portion 44 for fixating themedical device to the caput femur and/or the collum femur of the femoralbone.

FIG. 4 shows the medical device according to FIG. 3 in section, showingthe medical device comprising a plurality of channels in fluidconnection with a reservoir (not shown) through a conduit 1106 placedcentrally in the fixating portion 44, the channels 1105 being fullyintegrated in the medical device. The conduit 1106 transportslubricating fluid to the inlet 1123 for further distribution to thechannels 1105. The conduit ends up in a connecting section 1111 which isadapted to connect the conduit to a second conduit 1106 or a reservoir,or additional channels.

FIG. 5 shows a frontal view of the body of a human patient, illustratinga laparoscopic/arthroscopic method of operating the hip joint to providea medical device according to any of the embodiments herein from theopposite side from acetabulum 8. The hip joint comprises the acetabulum8 and the caput femur 5. The small incisions 14 in the abdominal wall ofthe human patient allows the insertion of laparoscopic/arthroscopictrocars 33 a,b,c into the body of the patients. Whereafter one or morecamera 34, a surgical instrument adapted to create a hole in the pelvicbone 35, or instruments 36 for introducing, placing, connecting,attaching, creating or filling an implantable medical device, can beinserted into the body through said laparoscopic/arthroscopic trocars 33a,b,c.

FIG. 6 shows a lateral view of the body of a human patient, with the hipjoint shown in section. The hip joint comprises a caput femur 5 placedat the very top of collum femur 6 which is the top part of the femurbone 7. The caput femur 5 is in connection with the acetabulum 8 whichis a bowl shaped part of the pelvic bone 9. Laparoscopic/arthroscopictrocars 33 a,b,c is being used to reach the hip joint 39 with one ormore camera 34, a surgical instrument 35 adapted to create a hole in thepelvic bone 9, or instruments 36 for introducing, placing, connecting,attaching, creating or filling an implantable medical device.

FIG. 7 shows the creation of a hole 18 in the pelvic bone 9, after thepelvic bone 9 has been dissected. The hole 18 is created from theabdominal side of the pelvic bone 9 through repetitive or continuousmovement of a hole creating device 22 placed into the human patient fromthe abdominal side of the pelvic bone 9. The hole 18 passes through thepelvic bone 9 from the opposite side from acetabulum 8 and into the hipjoint 19. According to a first embodiment the hole 18 is large whichallows an implantable medical device to pass through the hole 18 in itsfull functional size.

FIG. 8 a shows a second embodiment in which the hole 20 created in asurgical or laparoscopic/arthroscopic method is much smaller as shown inFIG. 8 a allowing the hole creating device 22 creating the hole 20 to besmaller, and thus also the incision and dissection performed in thehuman body.

FIG. 8 b shows the hip joint in section when a medical device has beenprovided between the caput femur 5 and the acetabulum. The medicaldevice according to this embodiment comprises multiple channels 1105connected to a conduit 1106 which in turn is connected to a connectingportion placed in the hole in the pelvic bone 9. The conduit 1106transports lubricating fluid to the inlet 1123 for further distributionto the channels 1105. For insertion through a hole 18 in the pelvic bone9 being smaller than the medical device the medical device could berolled or compressed, or according to another embodiment, moulded inplace either in a mould adapted to be resorbed by the human body, meltor serve as the surface of the medical device. The medical device couldbe adapted to be fixated using adhesive or a mechanical fixatingelement.

FIG. 9 a shows a hip joint in section when a medical device is beingprovided, through a hole 18 in the pelvic bone 9 for replacing thecontacting surface of the caput femur 5. The medical device comprises anartificial contacting surface 1103 b and a fixating portion 44 placedcentrally in the medical device and adapted to fixate the medical deviceto the caput femur 5. The medical device comprises a plurality ofchannels 1105 which exits at the artificial contacting surface forlubricating the hip joint. The channels are in fluid connection with aconduit 1106 which in turn is connected to an interconnecting part 1111b adapted to connect the conduit to a second conduit 1106 b or a secondportion of the conduit 1106 b, which in turn is in fluid connection witha reservoir 1108 placed in the femoral bone 7 of the human patient. Thereservoir 1108 is placed in the femoral bone 7 and is adapted to hold apressurized lubricating fluid, which according to the embodiment shownin FIG. 9 a is pressurized by means of said reservoir 1108 being springloaded by means of a spring 1109 in connection with a movable wallportion in the form of a piston 1110 pressurizing the lubricating fluid.The reservoir 1108 is furthermore connected to an injection port 1107which is positioned in connection with the femoral bone 7 below thegreater trochanter 1186, however, any other suitable placement is alsoconceivable, in connection with bone, in a cavity or subcutaneously. Themedical device is according to the embodiment of FIG. 9 a operable usinga pressurized reservoir, however according to other embodiments themedical device is operable by a powered operating device, such as animplantable pump, which could be powered by direct propulsion, such asinductive or magnetic propulsion, or by an accumulated energy source,such as a battery. The channels or conduits could according to oneembodiment (not shown) comprise a valve for closing the flow oflubricating fluid through the conduit 1106 or channel 1105, therebyclosing the connection between the reservoir and the artificialcontacting surface. The valve could be powered and adapted to becontrolled form outside of the human body by means of for example aremote control.

FIG. 9 b shows the hip joint in section when a medical device accordingto another embodiment has been provided to the hip joint, replacing thecontacting surface of the caput femur. The medical device comprises anartificial contacting surface 1103 b comprising a plurality of channels1105 which are connected to a conduit 1106, 1106 b placed in fixatingpart of the medical device. The conduit is in turn in fluid connectionwith a reservoir 1108 placed inside of the femoral bone, preferably inthe cancellous parts of the femoral bone, the reservoir is thereby influid connection with the channels of the medical device for lubricatingthe artificial contacting surface 1103 b of the medical device.

FIG. 10 shows the hip joint in section when an implantable medicaldevice adapted to replace the acetabulum contacting surface is beingprovided. The medical device comprises an artificial acetabulum surface65 comprising a plurality of channels connected to a conduit 1106 by aninter-connecting part 1111. The medical device is according to theembodiment shown in FIG. 10 adapted to be placed in a hole 18 in thepelvic bone 9 for replacing the acetabulum contacting surface 65. FIG.10 furthermore shows a unit to which the conduit 1106 is connected,according to one embodiment the unit comprises a reservoir 1108 and twopressure creating devices 1113 a, 1113 b adapted to create a pressurefor pressurizing the lubricating fluid for pressing said lubricatingfluid through the conduit 1106 and further through the plurality ofchannels 1105 for lubricating the implantable medical device. Theconduit 1106 transports lubricating fluid to the inlet 1123 for furtherdistribution to the channels 1105. The pressure creating devices couldbe spring loaded or comprise of a pressurized gas filled element whichis further pressurized by the injecting of a lubricating fluid into thereservoir 1108. The unit further comprises an injection port 1107 whichcomprises a self sealing membrane 1112, which preferably is a Parylenecoated silicone membrane. According to another embodiment the unitcomprises a powered operation device such as a pump housed in thecontainer 1113 a which pumps the lubricating fluid from the reservoir1108 through the conduit 1106 to the plurality of channels 1105.According to one embodiment the pump is powered by a battery housed inthe compartment 1113 b.

FIG. 11 a shows a surgical instrument adapted to insert a medical deviceaccording to any of the embodiments herein, or a mould for creating amedical device, according to a first embodiment. The surgical instrumentcomprises a gripping portion 76 and a handling portion 77. According tothe embodiments shown in FIG. 11 a,b,c the instrument further comprisesa rotation element 78 that enables the gripping part 76 to rotate inrelation to the handling part 77, however it is equally conceivable thatthe surgical instrument lacks this rotation element 78.

FIG. 11 b shows the surgical instrument adapted to insert a prosthesis,prosthetic parts or parts needed to create or provide a hip jointsurface, according to a second embodiment. According to this embodimentthe surgical instrument further comprises a parallel displaced section79, which increases the reach of the instrument and facilitates thereaching of the hip joint through a hole in the pelvic bone from theopposite side from acetabulum.

FIG. 11 c shows the surgical instrument adapted to insert a prosthesis,prosthetic parts or parts needed to create or provide a hip jointsurface, according to a third embodiment. According to this embodimentthe surgical instrument further comprises two angle adjusting members 80a,b. The angle adjusting members could be adjustable for varying theangle of said gripping part 76 in relation to the handling portion 77,or fixed in an angle suitable for creating operating in a hip jointthrough a hole in the pelvic bone from the opposite side from acetabulum8.

FIG. 12 shows the hip joint in section when a medical device has beenprovided. The implantable medical device is adapted to replace theacetabulum surface and is inserted through a hole 18 in the pelvic bone9, however, in other embodiments it is equally conceivable that themedical device is adapted to be inserted through a hole in the femoral 7bone or the hip joint capsule. The medical device comprises a pluralityof channels 1105 interconnected through a conduit 1106 which places thechannels 1105 in fluid connection with each other. The conduit 1106transports lubricating fluid to the inlet 1123 for further distributionto the channels 1105. The conduit 1106 is further connected to a firstportion of an interconnecting part 1111 which is adapted to be connectedto a second portion of an interconnecting part 1111 b. Theinterconnecting part 1111 connects a first portion of the conduit 1106to a second portion of the conduit 1106, enabling a first portion of theconduit 1106 to be inserted from the acetabulum side of the pelvic bone9 and a second portion of the conduit 1106 to be inserted from thepelvic side, or opposite acetabulum side of the pelvic bone 9. Theconnection of two portions of the conduit 1106 is particularlybeneficial when the medical device has been inserted through a hole 18in the femoral bone 7 or the hip joint capsule and the reservoir 1108 isimplanted in the abdominal region of the human patient, or in anotherarea on the abdominal side of the pelvic bone 9. The conduit 1106 isthen further connected to the reservoir 1108 and adapted to transport alubricating fluid from the reservoir 1108 to an area of the hip joint.The reservoir 1108 is according to the embodiment shown in FIG. 12adapted to place the lubricating fluid under pressure by means of aspring 1109 exerting a force on a movable wall portion in the form of apiston 1110 pressing the lubricating fluid through the conduit 1106 andfurther through the channels 1105. The reservoir 1108 further comprisesan injection port 1107 placed in the top part of the reservoir 1108 forrefilling the reservoir 1108 and in the same event increasing thepressure of the lubricating fluid.

FIG. 13 a shows a human patient in a lateral view showing the hip jointin section. The femoral bone 7 has a proximal part comprising the collumfemur 6 and most proximal the caput femur 5. In FIG. 13 a a hole 82 isbeing created from an incision made in the thigh, the hole travels intothe femoral bone 7, following the collum femur 6 and exiting through thecaput femur 5 and thus into the hip joint. The hole is used to providethe hip joint with a medical device which preferably is possible to rollor bend for insertion through said hole 82.

FIG. 13 b shows the hip joint in section when the medical device hasbeen provided through the hole 82 in the femoral bone 7 and fixated inthe acetabulum bowl 8. The medical device comprises a plurality ofchannels 1105 connected to each other by a conduit 1106. According toother embodiments, the medical device could be provided through the hipjoint capsule, or a hole in the pelvic bone 9. After the medical devicehas been provided, a tool 1180 housing a reservoir 1108 connected to aconduit 1106′ is used to provide the reservoir 1108 to the hole 82 inthe femoral bone 7 and to connect the reservoir to the conduit 1106 ofthe medical device.

FIG. 13 c shows the hip joint in section when the reservoir 1108, placedin the hole 82 in the femoral bone 7 has been connected to the medicaldevice. Furthermore a conduit 1106′ reaching from the reservoir 1108 toan injection port 1107 for refilling and/or pressurizing the reservoir1108.

FIG. 13 d shows the reservoir unit in further detail, the reservoir unitcomprises an interconnecting portion 1111 placed at the end part of thereservoir unit, a pressurized reservoir 1108, which according to theembodiment of FIG. 13 d is pressurized by means of a spring 1109 pushinga movable wall portion 1110 in the form of a piston 1110. The reservoirunit further comprises a conduit 1106′ in connection with the reservoir,and in connection with an injection port 1107, for filling the and/orpressurizing the reservoir 1108 comprising the lubricating fluid. Theinjection port 1107 comprises a self sealing membrane, which could be aself sealing Parylene coated silicone membrane, to inhibit cellmigration on the surface of the injection port. The section A-A showsthe centrally placed conduit 1106 in the center of the reservoir 1108for filling and/or pressurizing the reservoir 1108.

FIG. 14 shows a lateral view of a human patient in section, when alubricating fluid is being injected into an injection port 1107, bymeans of an injecting member 92 comprising a container 1115 adapted tocontain the lubricating fluid to be injected. The injection port isconnected to an implantable medical device placed in the hip jointthrough a conduit 1106 adapted to supply the fluid connection betweenthe injection port and the medical device. The medical device in turncomprises a plurality of channels 1105 for lubricating the artificialcontacting surfaces and thereby lubricating the hip joint. According tothe embodiment shown in FIG. 14 the medical device has been suppliedfrom the abdominal side of the pelvic bone 9 through a hole made in thepelvic bone which afterwards has been refilled with the removed boneplug and sealed and fixated with a mechanical fixating part attachedwith screws. According to other embodiments the medical device isprovided from the hip joint side of the pelvic bone 9 through the hipjoint capsule 12 or the femoral bone 7 and thereafter connected to theconduit 1106 on the abdominal side of the pelvic bone 9 through aninterconnecting part 1111. This enables the placing of the injectionport 1107 in the abdominal region, subcutaneously, in a cavity and/orsupported by the muscular or fascia tissue.

FIG. 15 shows the medical device in an opposite embodiment where themedical device comprises a first artificial contacting surface 112comprising a convex shape towards a centre of the hip joint. The firstartificial contacting surface 112 is adapted to be fixated to the pelvicbone 9 of the human patient. The artificial convex hip joint surface 112is adapted to be fixated to the pelvic bone 9, and is adapted to beinserted through a hole 18 in the pelvic bone 9. The medical devicecomprises a nut 120, comprising threads for securely fixating themedical device to the pelvic bone 9. The medical device furthercomprises a prosthetic part 118 adapted to occupy the hole 18 created inthe pelvic bone 9 after the medical device has been implanted in thepatient. The prosthetic part 118 comprises supporting members 119adapted to be in contact with the pelvic bone 9 and assist in thecarrying of the load placed on the medical device from the weight of thehuman patient in normal use. Normal use is defined as the same as aperson would use a natural hip joint. Further the medical devicecomprises a locking element 116 comprising a surface 117 adapted to bein contact with the artificial convex hip joint surface 112. The lockingelement 116 further comprises fixating members 115 which are adapted toassist in the fixation of the locking member 116 to the caput femur 5 orcollum femur 6, which in turns fixates the artificial convex hip jointsurface 112. The artificial convex hip joint surface 112 is fixated to aattachment rod 113 comprising a thread 114 that corresponds to thethread of the nut 120 in connection with the prosthetic part 118. Themedical device comprises a plurality of channels 1105 adapted tolubricate the artificial contacting surface 112. The plurality ofchannels 1105 are connected to each other through a conduit 1106 adaptedto transport a lubricating fluid from a reservoir 1108 to the pluralityof channels 1105 which are fully integrated in the artificial contactingsurface 112 of the medical device for lubricating the artificialcontacting surface 112 and thereby lubricating the hip joint.

FIG. 16 shows the medical device according to FIG. 15 when said medicaldevice is placed inside of the hip joint. The first artificialcontacting surface 112 comprising a convex shape towards a centre of thehip joint is positioned in a second artificial contacting surface 109comprising a concave shape towards the centre of the hip joint. Thesecond artificial contacting surface 109 is placed and fixated in thecaput 5 and collum femur 6 of the femoral bone an secured by a lockingelement 116 comprising a surface 117 facing the first artificial convexcontacting surface 112. The medical device comprises a plurality ofchannels 1105 which are connected to a conduit 1106 placed centrally inthe medical device for providing a lubricating fluid to the medicaldevice and lubricate the artificial contacting surface 112 and therebythe hip joint.

FIG. 17 shows the providing of a prosthetic part 118 to the hole 18 inthe pelvic bone 9. The prosthetic part 118 comprises supporting members119 adapted to be in contact with the pelvic bone 9 and assist in thecarrying of the load placed on the medical device from the weight of thehuman patient in normal use.

FIG. 18 shows an alternative embodiment of the medical device in theopposite embodiment in which the part of the medical device comprisingan artificial concave hip joint surface placed in the caput 5 and collumfemur 6 comprises a plurality of lubricating channels 1105 which areconnected to a conduit 1106 b establishing a fluid connection betweenthe medical device and the reservoir located in the cancellous bone ofthe collum femur 6. The reservoir is adapted to be refilled through aninjection port 1107 which according to the embodiment of FIG. 18 isplaced in connection with the femoral bone 7 and situated below thegreater trochanter 1186. The reservoir unit, and the function thereof,is described in further detail with reference to FIGS. 9 a and 9 b. FIG.18 furthermore shows the prosthetic part 118, when fixated to the pelvicbone 9 using screws 121. The screws could be assisted or replaced by anadhesive which could be applied in connection to the screws or at thesurface S between the prosthetic part and the pelvic bone 9.

FIG. 19 shows the right leg of a human patient. The femoral bone 102having a distal part comprising the lateral condyle 105, the medialcondyle 106 and an area between said lateral and said medial condyle.The sections of the distal part of the femoral bone 102 comprisecontacting surfaces of the knee joint. The knee joint furthermorecomprises the patella 101, which is a triangular bone which articulateswith the femur 102 and covers and protects the knee joint. The kneejoint also comprises the minisci 107, 108 which are cartilaginouselements within the knee joint which serve as articulating surfaces toprotect the ends of the bones from rubbing on each other. The minisci107, 108 also acts as shock absorbers in the knee joint, to absorb theshocks from the movement of the human patient. There are two menisci107,108 in each knee, the medial meniscus 107 and the lateral meniscus108. In patients with osteoarthritis the menisci 107, 108 which acts asarticulating surfaces i.e. weight carrying surfaces are worn away and,in extreme cases, bone can be exposed in the joint. The knee joint isprotected by the knee joint capsule also known as the articular capsuleof the knee joint or the capsular ligament of the knee joint. The kneejoint capsule is wide and lax; thin in front and at the side; andcontains the patella 101, ligaments, menisci 107,108, and bursae, whichare small fluid-filled sacs made of white fibrous tissue. The knee jointcapsule consists of a synovial and a fibrous membrane separated by fattydeposits anteriorly and posteriorly.

FIG. 20 shows the knee joint when artificial knee joint surfaces 130,116 a has been provided to the distal part of the femoral bone 102 andthe proximal part of the tibia bone 104. A lateral and medial channel125 a,b supplies the contacting surfaces and thereby the knee joint withlubricating fluid for reducing the friction of the knee joint.

FIG. 21 shows the body of a human patient in a frontal view where areservoir unit 127 is implanted subcutaneously in the abdominal regionof the human patient. The reservoir unit according to this embodimentcomprises an operating device in the form of a pump 130 which is poweredby a battery 128 for pumping a fluid from the reservoir 129 through aconduit to a channel 125 supplying the artificial contacting surfaces ofthe knee joint with a lubricating fluid. The reservoir unit is fixatedto the muscular or fascia tissue 1181 of the abdominal wall through themuscular or fascia 1181 tissue being clamped between the reservoir unitand the injection port 1107 arranged at the outside of the muscular orfascia tissue 1181.

FIG. 22 a shows an embodiment where the medical device comprises anartificial knee joint 115 surface clamps the medial, lateral or both themedial and lateral condyle 106 of the knee joint, being the distalportion of the femoral bone 7. The medical device, according to thisembodiment comprises a plurality of channels 1105 for lubricating theartificial contacting surfaces, the plurality of channels are in fluidconnection with each other through a conduit 1106 which in turn is influid connection with a reservoir 1108 comprising an injection port 1107for refilling the reservoir or pressurizing the lubricating fluidcontained in said reservoir 1108. The conduit 1106 transportslubricating fluid to the inlet 1123 for further distribution to thechannels 1105.

FIG. 22 b shows the knee joint in a lateral view when a medical devicecomprising an artificial contacting surface 1102 has been provided tothe proximal part of the tibia bone 104, which together with the fibulabone 103 makes up the lower part of the leg. The artificial knee jointsurface comprises a plurality of channels 1105 which are in fluidconnection with a conduit 1106 adapted to transport lubricating fluidfrom a reservoir 1108. The reservoir 1108 is according to the embodimentof FIG. 22 b placed at the rear side of the tibia bone 104 and fixatedto the tibia bone 104 and comprises an injection port 1107 for injectinga lubricating fluid into the reservoir 1108 and/or pressurizing alubricating fluid contained in the reservoir 1108. The conduit 1106transports lubricating fluid to the inlet 1123 for further distributionto the channels 1105.

FIG. 23 shows the medical device for implantation in a knee joint infurther detail. The medical device comprises a plurality of channels1105 placed along the artificial contacting surface of the medicaldevice, for lubricating the contacting surface of the medical device.The channels 1105 are connected to a conduit 1106 for transport of thelubricating fluid along the artificial contacting surface 1101 of themedical device. The conduit 1106 transports lubricating fluid to theinlets 1123 for further distribution to the channels 1105.

FIG. 24 shows a sectional side-view of the medical device displaying thechannels 1105 being fully integrated in the artificial contactingsurface and connected to each other, the conduit 1106 supplies the 1105channels with lubricating fluid for lubricating the artificialcontacting surface of the medical device. The conduit 1106 transportslubricating fluid to the inlet 1123 for further distribution to thechannels 1105.

FIG. 25 a shows a medical device for implantation in a knee joint of ahuman patient, the medical device comprises a several medical deviceparts 119 adapted to be connected to each other and to a medical devicebase part 118 by means of mechanical fixation elements 120 supplying aform fitting between the plurality of medical device parts 119 and thebase part 118. The medical device base part 118 furthermore comprises afixation portion 117 which is adapted to supply mechanical fixation ofthe medical device to a human bone, such as the proximal part of thetibia bone. The medical device base part 118 furthermore comprises achannel for supplying a lubricating fluid to the artificial contactingsurface of the knee joint.

FIG. 25 b shows the medical device according to FIG. 25 a, whenassembled.

FIG. 26 shows the medical device according to FIGS. 25 a and 25 b whenthe medical device is being fixated to the tibia bone 104.

FIG. 27 shows the proximal part of the tibia bone when a medical devicecomprising an artificial contacting surface 116 has been fixated to thetibia bone 104. The channel 1105 of the artificial contacting surface isconnected to a conduit 1106 which supplies a fluid connection betweenthe channel 1105 of the medical device and a first and second reservoir1108 placed inside of the tibia bone 1104 on the medial and lateralside. The conduit further connects the first and second reservoir to aninjection port 1107 placed on the medial side of the pelvic bone forrefilling and/or pressurizing the reservoirs 1108. The reservoirs 1108,according to the embodiment shown in FIG. 27 are adapted to place thelubricating fluid under pressure, thereby pressing the lubricating fluidout of the channels 1105 onto the artificial contacting surface, forlubricating the knee joint. For this purpose, the reservoir 1108comprises a spring 1109 which is in connection with a movable wallportion in the form of a piston 1110, for pressing the lubricatingfluid.

FIG. 28 shows the human patient in a frontal view when an implantablelubrication system 120 has been implanted. The implantable lubricationsystem 120 is adapted to inject a lubricating fluid continuously,intermittently or when needed into said hip joint. According to theembodiment shown in FIG. 61 the implantable lubricating system comprisestwo interconnected units 121, 122. The two interconnected units areplaced in the abdominal region of the human patient and is in connectionwith the hip joint through a conduit 1106.

FIG. 29 shows the implantable lubricating system 120, which could beused in combination with any of the medical devices described herein, infurther detail. According to the embodiment shown, the implantablelubricating system comprises a first unit 121 comprising a pumpingmember 123 adapted to pump the lubricating fluid from a reservoir 1108to an area of the hip joint. The first unit 121 furthermore comprises aninjection port 1107 for filling the reservoir 1108 from outside of thehuman body without having to perform a surgical procedure. The injectionport 1107 comprises a self-sealing membrane which is penetratable with aneedle attached to a syringe. The first unit 121 further comprises areceiver of wireless energy 124 preferably comprising a coil. Saidreceiver of wireless energy is used to charge a battery 126. Accordingto this embodiment the implantable lubrication system 120 furthercomprises a second unit 122 which in turn comprises a battery 126 and afluid reservoir 1108. The lubricating fluid 128 is pumped from thereservoir 1108, through the first unit 121 with the pumping device,through the conduit 1106 and into the area of the hip joint where ithelps lubricating the hip joint surfaces or the artificial contactingsurfaces of the implantable medical device. The lubricating fluid ispreferably a biocompatible lubricating fluid such as hyaluronic acid.

FIG. 30 shows the implantable lubricating system adapted to be used withany of the medical device herein, according to an embodiment wherein theimplantable lubricating system is a circulating lubricating systemcomprising one inlet 130 into the joint to be lubricated and one outlet131. Preferably this system is a system for continuous lubrication wherethe pumping member 123 continuously circulates the lubricating fluid 128inside of the hip joint.

FIG. 31 shows an implantable lubricating system for circulatinglubrication adapted to be used with any of the medical device herein,wherein the lubricating system further comprises a filtering member 132for filtering the lubricating fluid. The filter is adapted to be selfcleaning and the out filtered matter is disposed through the disposalchannel 133, either into the abdomen of the human patient, or into acontainer attached to the disposal channel 133. Through the filtering ofthe lubricating fluid 128 the circulating lubricating system can operatefor long periods without the need of any surgical procedures.

FIG. 32 shows the lubricating fluid of FIG. 29, when lubricating animplantable medical device comprising an artificial contacting surface45 by providing a lubricating fluid 128.

FIG. 33 a shows a lubricating system, which could be adapted to be usedin combination with any of the medical devices herein, according toanother embodiment wherein the lubricating system comprises a unit 1310comprising a retractable needle 1311 fixated to an operating system foroperating said retractable needle 1311. The needle is adapted topenetrate a self sealing membrane 1314 placed in the pelvic bone 9 forinjecting a lubricating fluid into the hip joint. A conduit 1106 isadapted to supply the unit 1310 with a lubricating fluid from aninjection port and/or from an additional reservoir which could beimplanted subcutaneously or in a cavity of the body.

FIG. 33 b shows the lubricating system in a state in which theretractable needle 1311 is in its advanced position by the operatingdevice having operated the retractable needle 1311. The needle therebypenetrates the self sealing membrane 1314 and is placed in a position inwhich injection of a lubricating fluid is possible.

FIG. 34 illustrates a system for treating a disease comprising anapparatus 10 of the present invention placed in the abdomen of apatient. An implanted energy-transforming device 1002 is adapted tosupply energy consuming components of the apparatus with energy via apower supply line 1003. An external energy-transmission device 1004 fornon-invasively energizing the apparatus 10 transmits energy by at leastone wireless energy signal. The implanted energy-transforming device1002 transforms energy from the wireless energy signal into electricenergy which is supplied via the power supply line 1003.

The implanted energy-transforming device 1002 may also comprise othercomponents, such as: a coil for reception and/or transmission of signalsand energy, an antenna for reception and/or transmission of signals, amicrocontroller, a charge control unit, optionally comprising an energystorage, such as a capacitor, one or more sensors, such as temperaturesensor, pressure sensor, position sensor, motion sensor etc., atransceiver, a motor, optionally including a motor controller, a pump,and other parts for controlling the operation of a medical implant.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.

The wireless energy-transmission device 1004 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.

Generally speaking, the energy-transforming device 1002 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 1004 into energy of a second form, whichtypically is different from the energy of the first form. The implantedapparatus 10 is operable in response to the energy of the second form.The energy-transforming device 1002 may directly power the apparatuswith the second form energy, as the energy-transforming device 1002transforms the first form energy transmitted by the energy-transmissiondevice 1004 into the second form energy. The system may further includean implantable accumulator, wherein the second form energy is used atleast partly to charge the accumulator.

Alternatively, the wireless energy transmitted by theenergy-transmission device 1004 may be used to directly power theapparatus, as the wireless energy is being transmitted by theenergy-transmission device 1004. Where the system comprises an operationdevice for operating the apparatus, as will be described below, thewireless energy transmitted by the energy-transmission device 1004 maybe used to directly power the operation device to create kinetic energyfor the operation of the apparatus.

The wireless energy of the first form may comprise sound waves and theenergy-transforming device 1002 may include a piezo-electric element fortransforming the sound waves into electric energy. The energy of thesecond form may comprise electric energy in the form of a direct currentor pulsating direct current, or a combination of a direct current andpulsating direct current, or an alternating current or a combination ofa direct and alternating current. Normally, the apparatus compriseselectric components that are energized with electrical energy. Otherimplantable electric components of the system may be at least onevoltage level guard or at least one constant current guard connectedwith the electric components of the apparatus.

Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy-transmission device may be controlled from outside thepatient's body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating theapparatus. Alternatively, the energy-transmission device is controlledfrom outside the patient's body to release non-magnetic wireless energy,and the released non-magnetic wireless energy is used for operating theapparatus.

The external energy-transmission device 1004 also includes a wirelessremote control having an external signal transmitter for transmitting awireless control signal for non-invasively controlling the apparatus.The control signal is received by an implanted signal receiver which maybe incorporated in the implanted energy-transforming device 1002 or beseparate there from.

The wireless control signal may include a frequency, amplitude, or phasemodulated signal or a combination thereof. Alternatively, the wirelesscontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal. Alternatively, thewireless control signal comprises an electric or magnetic field, or acombined electric and magnetic field.

The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.

FIG. 35 illustrates the system of FIG. 34 in the form of a moregeneralized block diagram showing the apparatus 10, theenergy-transforming device 1002 powering the apparatus 10 via powersupply line 1003, and the external energy-transmission device 1004, Thepatient's skin 1005, generally shown by a vertical line, separates theinterior of the patient to the right of the line from the exterior tothe left of the line.

FIG. 36 shows an embodiment of the invention identical to that of FIG.35, except that a reversing device in the form of an electric switch1006 operable for example by polarized energy also is implanted in thepatient for reversing the apparatus 10. When the switch is operated bypolarized energy the wireless remote control of the externalenergy-transmission device 1004 transmits a wireless signal that carriespolarized energy and the implanted energy-transforming device 1002transforms the wireless polarized energy into a polarized current foroperating the electric switch 1006. When the polarity of the current isshifted by the implanted energy-transforming device 1002 the electricswitch 1006 reverses the function performed by the apparatus 10.

FIG. 37 shows an embodiment of the invention identical to that of FIG.35, except that an operation device 1007 implanted in the patient foroperating the apparatus 10 is provided between the implantedenergy-transforming device 1002 and the apparatus 10. This operationdevice can be in the form of a motor 1007, such as an electricservomotor. The motor 1007 is powered with energy from the implantedenergy-transforming device 1002, as the remote control of the externalenergy-transmission device 1004 transmits a wireless signal to thereceiver of the implanted energy-transforming device 1002.

FIG. 38 shows an embodiment of the invention identical to that of FIG.35, except that it also comprises an operation device in the form of anassembly 1008 including a motor/pump unit 1009 and a fluid reservoir1010 is implanted in the patient. In this case the apparatus 10 ishydraulically operated, i.e. hydraulic fluid is pumped by the motor/pumpunit 1009 from the fluid reservoir 1010 through a conduit 1011 to theapparatus 10 to operate the apparatus, and hydraulic fluid is pumped bythe motor/pump unit 1009 back from the apparatus 10 to the fluidreservoir 1010 to return the apparatus to a starting position. Theimplanted energy-transforming device 1002 transforms wireless energyinto a current, for example a polarized current, for powering themotor/pump unit 1009 via an electric power supply line 1012.

Instead of a hydraulically operated apparatus 10, it is also envisagedthat the operation device comprises a pneumatic operation device. Inthis case, the hydraulic fluid can be pressurized air to be used forregulation and the fluid reservoir is replaced by an air chamber.

In all of these embodiments the energy-transforming device 1002 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the system.

As an alternative, the wireless remote control described above may bereplaced by manual control of any implanted part to make contact with bythe patient's hand most likely indirect, for example a press buttonplaced under the skin.

FIG. 39 shows an embodiment of the invention comprising the externalenergy-transmission device 1004 with its wireless remote control, theapparatus 10, in this case hydraulically operated, and the implantedenergy-transforming device 1002, and further comprising a hydraulicfluid reservoir 1013, a motor/pump unit 1009 and an reversing device inthe form of a hydraulic valve shifting device 1014, all implanted in thepatient. Of course the hydraulic operation could easily be performed byjust changing the pumping direction and the hydraulic valve maytherefore be omitted. The remote control may be a device separated fromthe external energy-transmission device or included in the same. Themotor of the motor/pump unit 1009 is an electric motor. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 1004, the implanted energy-transformingdevice 1002 powers the motor/pump unit 1009 with energy from the energycarried by the control signal, whereby the motor/pump unit 1009distributes hydraulic fluid between the hydraulic fluid reservoir 1013and the apparatus 10. The remote control of the externalenergy-transmission device 1004 controls the hydraulic valve shiftingdevice 1014 to shift the hydraulic fluid flow direction between onedirection in which the fluid is pumped by the motor/pump unit 1009 fromthe hydraulic fluid reservoir 1013 to the apparatus 10 to operate theapparatus, and another opposite direction in which the fluid is pumpedby the motor/pump unit 1009 back from the apparatus 10 to the hydraulicfluid reservoir 1013 to return the apparatus to a starting position.

FIG. 40 shows an embodiment of the invention comprising the externalenergy-transmission device 1004 with its wireless remote control, theapparatus 10, the implanted energy-transforming device 1002, animplanted internal control unit 1015 controlled by the wireless remotecontrol of the external energy-transmission device 1004, an implantedaccumulator 1016 and an implanted capacitor 1017. The internal controlunit 1015 arranges storage of electric energy received from theimplanted energy-transforming device 1002 in the accumulator 1016, whichsupplies energy to the apparatus 10. In response to a control signalfrom the wireless remote control of the external energy-transmissiondevice 1004, the internal control unit 1015 either releases electricenergy from the accumulator 1016 and transfers the released energy viapower lines 1018 and 1019, or directly transfers electric energy fromthe implanted energy-transforming device 1002 via a power line 1020, thecapacitor 1017, which stabilizes the electric current, a power line 1021and the power line 1019, for the operation of the apparatus 10.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the apparatus 10 according to a pre-programmedtime-schedule or to input from any sensor sensing any possible physicalparameter of the patient or any functional parameter of the system.

In accordance with an alternative, the capacitor 1017 in the embodimentof FIG. 40, 10 may be omitted. In accordance with another alternative,the accumulator 1016 in this embodiment may be omitted.

FIG. 41 shows an embodiment of the invention identical to that of FIG.35, except that a battery 1022 for supplying energy for the operation ofthe apparatus 10 and an electric switch 1023 for switching the operationof the apparatus 10 also are implanted in the patient. The electricswitch 1023 may be controlled by the remote control and may also beoperated by the energy supplied by the implanted energy-transformingdevice 1002 to switch from an off mode, in which the battery 1022 is notin use, to an on mode, in which the battery 1022 supplies energy for theoperation of the apparatus 10.

FIG. 42 shows an embodiment of the invention identical to that of FIG.41, except that an internal control unit 1015 controllable by thewireless remote control of the external energy-transmission device 1004also is implanted in the patient. In this case, the electric switch 1023is operated by the energy supplied by the implanted energy-transformingdevice 1002 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 1015 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 1015 torelease electric energy from the battery 1022 for the operation of theapparatus 10.

FIG. 43 shows an embodiment of the invention identical to that of FIG.42, except that an accumulator 1016 is substituted for the battery 1022and the implanted components are interconnected differently. In thiscase, the accumulator 1016 stores energy from the implantedenergy-transforming device 1002. In response to a control signal fromthe wireless remote control of the external energy-transmission device1004, the internal control unit 1015 controls the electric switch 1023to switch from an off mode, in which the accumulator 1016 is not in use,to an on mode, in which the accumulator 1016 supplies energy for theoperation of the apparatus 10. The accumulator may be combined with orreplaced by a capacitor.

FIG. 44 shows an embodiment of the invention identical to that of FIG.43, except that a battery 1022 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 1004, the internal control unit 1015 controlsthe accumulator 1016 to deliver energy for operating the electric switch1023 to switch from an off mode, in which the battery 1022 is not inuse, to an on mode, in which the battery 1022 supplies electric energyfor the operation of the apparatus 10.

Alternatively, the electric switch 1023 may be operated by energysupplied by the accumulator 1016 to switch from an off mode, in whichthe wireless remote control is prevented from controlling the battery1022 to supply electric energy and is not in use, to a standby mode, inwhich the wireless remote control is permitted to control the battery1022 to supply electric energy for the operation of the apparatus 10.

It should be understood that the switch 1023 and all other switches inthis application should be interpreted in its broadest embodiment. Thismeans a transistor, MCU, MCPU, ASIC, FPGA or a DA converter or any otherelectronic component or circuit that may switch the power on and off.Preferably the switch is controlled from outside the body, oralternatively by an implanted internal control unit.

FIG. 45 shows an embodiment of the invention identical to that of FIG.41, except that a motor 1007, a mechanical reversing device in the formof a gear box 1024, and an internal control unit 1015 for controllingthe gear box 1024 also are implanted in the patient. The internalcontrol unit 1015 controls the gear box 1024 to reverse the functionperformed by the apparatus 10 (mechanically operated). Even simpler isto switch the direction of the motor electronically. The gear boxinterpreted in its broadest embodiment may stand for a servo arrangementsaving force for the operation device in favor of longer stroke to act.

FIG. 46 shows an embodiment of the invention identical to that of FIG.52 except that the implanted components are interconnected differently.Thus, in this case the internal control unit 1015 is powered by thebattery 1022 when the accumulator 1016, suitably a capacitor, activatesthe electric switch 1023 to switch to an on mode. When the electricswitch 1023 is in its on mode the internal control unit 1015 ispermitted to control the battery 1022 to supply, or not supply, energyfor the operation of the apparatus 10.

FIG. 47 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the apparatus 10, the internal control unit 1015,motor or pump unit 1009, and the external energy-transmission device1004 including the external wireless remote control. As alreadydescribed above the wireless remote control transmits a control signalwhich is received by the internal control unit 1015, which in turncontrols the various implanted components of the apparatus.

A feedback device, preferably comprising a sensor or measuring device1025, may be implanted in the patient for sensing a physical parameterof the patient. The physical parameter may be at least one selected fromthe group consisting of pressure, volume, diameter, stretching,elongation, extension, movement, bending, elasticity, musclecontraction, nerve impulse, body temperature, blood pressure, bloodflow, heartbeats and breathing. The sensor may sense any of the abovephysical parameters. For example, the sensor may be a pressure ormotility sensor. Alternatively, the sensor 1025 may be arranged to sensea functional parameter. The functional parameter may be correlated tothe transfer of energy for charging an implanted energy source and mayfurther include at least one selected from the group of parametersconsisting of; electricity, any electrical parameter, pressure, volume,diameter, stretch, elongation, extension, movement, bending, elasticity,temperature and flow.

The feedback may be sent to the internal control unit or out to anexternal control unit preferably via the internal control unit. Feedbackmay be sent out from the body via the energy transfer system or aseparate communication system with receiver and transmitters.

The internal control unit 1015, or alternatively the external wirelessremote control of the external energy-transmission device 1004, maycontrol the apparatus 10 in response to signals from the sensor 1025. Atransceiver may be combined with the sensor 1025 for sending informationon the sensed physical parameter to the external wireless remotecontrol. The wireless remote control may comprise a signal transmitteror transceiver and the internal control unit 1015 may comprise a signalreceiver or transceiver. Alternatively, the wireless remote control maycomprise a signal receiver or transceiver and the internal control unit1015 may comprise a signal transmitter or transceiver. The abovetransceivers, transmitters and receivers may be used for sendinginformation or data related to the apparatus 10 from inside thepatient's body to the outside thereof.

Where the motor/pump unit 1009 and battery 1022 for powering themotor/pump unit 1009 are implanted, information related to the chargingof the battery 1022 may be fed back. To be more precise, when charging abattery or accumulator with energy feed back information related to saidcharging process is sent and the energy supply is changed accordingly.

FIG. 48 shows an alternative embodiment wherein the apparatus 10 isregulated from outside the patient's body. The system 1000 comprises abattery 1022 connected to the apparatus 10 via a subcutaneous electricswitch 1026. Thus, the regulation of the apparatus 10 is performednon-invasively by manually pressing the subcutaneous switch, whereby theoperation of the apparatus 10 is switched on and off. It will beappreciated that the shown embodiment is a simplification and thatadditional components, such as an internal control unit or any otherpart disclosed in the present application can be added to the system.Two subcutaneous switches may also be used. In the preferred embodimentone implanted switch sends information to the internal control unit toperform a certain predetermined performance and when the patient pressthe switch again the performance is reversed.

FIG. 49 shows an alternative embodiment, wherein the system 1000comprises a hydraulic fluid reservoir 1013 hydraulically connected tothe apparatus. Non-invasive regulation is performed by manually pressingthe hydraulic reservoir connected to the apparatus. Alternatively, thehydraulic fluid reservoir 1013 is adapted to work with an injection portfor the injection of hydraulic fluid, preferably for calibration ofhydraulic fluid.

The system may include an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator. The internal communicator feeds data related to theapparatus or the patient to the external data communicator and/or theexternal data communicator feeds data to the internal data communicator.

FIG. 50 schematically illustrates an arrangement of the system that iscapable of sending information from inside the patient's body to theoutside thereof to give feedback information related to at least onefunctional parameter of the apparatus or system, or related to aphysical parameter of the patient, in order to supply an accurate amountof energy to an implanted internal energy receiver 1002 connected toimplanted energy consuming components of the apparatus 10. Such anenergy receiver 1002 may include an energy source and/or anenergy-transforming device. Briefly described, wireless energy istransmitted from an external energy source 1004 a located outside thepatient and is received by the internal energy receiver 1002 locatedinside the patient. The internal energy receiver is adapted to directlyor indirectly supply received energy to the energy consuming componentsof the apparatus 10 via a switch 1026. An energy balance is determinedbetween the energy received by the internal energy receiver 1002 and theenergy used for the apparatus 10, and the transmission of wirelessenergy is then controlled based on the determined energy balance. Theenergy balance thus provides an accurate indication of the correctamount of energy needed, which is sufficient to operate the apparatus 10properly, but without causing undue temperature rise.

In FIG. 50 the patient's skin is indicated by a vertical line 1005.Here, the energy receiver comprises an energy-transforming device 1002located inside the patient, preferably just beneath the patient's skin1005. Generally speaking, the implanted energy-transforming device 1002may be placed in the abdomen, thorax, muscle fascia (e.g. in theabdominal wall), subcutaneously, or at any other suitable location. Theimplanted energy-transforming device 1002 is adapted to receive wirelessenergy E transmitted from the external energy-source 1004 a provided inan external energy-transmission device 1004 located outside thepatient's skin 1005 in the vicinity of the implanted energy-transformingdevice 1002.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 1004 a and an adjacent secondary coil arranged inthe implanted energy-transforming device 1002. When an electric currentis fed through the primary coil, energy in the form of a voltage isinduced in the secondary coil which can be used to power the implantedenergy consuming components of the apparatus, e.g. after storing theincoming energy in an implanted energy source, such as a rechargeablebattery or a capacitor. However, the present invention is generally notlimited to any particular energy transfer technique, TET devices orenergy sources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted components of theapparatus. The term “energy used” is then understood to include alsoenergy stored by implanted components of the apparatus. A control deviceincludes an external control unit 1004 b that controls the externalenergy source 1004 a based on the determined energy balance to regulatethe amount of transferred energy. In order to transfer the correctamount of energy, the energy balance and the required amount of energyis determined by means of a determination device including an implantedinternal control unit 1015 connected between the switch 1026 and theapparatus 10. The internal control unit 1015 may thus be arranged toreceive various measurements obtained by suitable sensors or the like,not shown, measuring certain characteristics of the apparatus 10,somehow reflecting the required amount of energy needed for properoperation of the apparatus 10. Moreover, the current condition of thepatient may also be detected by means of suitable measuring devices orsensors, in order to provide parameters reflecting the patient'scondition. Hence, such characteristics and/or parameters may be relatedto the current state of the apparatus 10, such as power consumption,operational mode and temperature, as well as the patient's conditionreflected by parameters such as; body temperature, blood pressure,heartbeats and breathing. Other kinds of physical parameters of thepatient and functional parameters of the device are described elsewhere.

Furthermore, an energy source in the form of an accumulator 1016 mayoptionally be connected to the implanted energy-transforming device 1002via the control unit 1015 for accumulating received energy for later useby the apparatus 10. Alternatively or additionally, characteristics ofsuch an accumulator, also reflecting the required amount of energy, maybe measured as well. The accumulator may be replaced by a rechargeablebattery, and the measured characteristics may be related to the currentstate of the battery, any electrical parameter such as energyconsumption voltage, temperature, etc. In order to provide sufficientvoltage and current to the apparatus 10, and also to avoid excessiveheating, it is clearly understood that the battery should be chargedoptimally by receiving a correct amount of energy from the implantedenergy-transforming device 1002, i.e. not too little or too much. Theaccumulator may also be a capacitor with corresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 1015. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 1015 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the apparatus 10, or the patient, or an implanted energysource if used, or any combination thereof. The internal control unit1015 is further connected to an internal signal transmitter 1027,arranged to transmit a control signal reflecting the determined requiredamount of energy, to an external signal receiver 1004 c connected to theexternal control unit 1004 b. The amount of energy transmitted from theexternal energy source 1004 a may then be regulated in response to thereceived control signal.

Alternatively, the determination device may include the external controlunit 1004 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 1004 b wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 1004 b, thus integrating the above-describedfunction of the internal control unit 1015 in the external control unit1004 b. In that case, the internal control unit 1015 can be omitted andthe sensor measurements are supplied directly to the internal signaltransmitter 1027 which sends the measurements over to the externalsignal receiver 1004 c and the external control unit 1004 b. The energybalance and the currently required amount of energy can then bedetermined by the external control unit 1004 b based on those sensormeasurements.

Hence, the present solution according to the arrangement of FIG. 50employs the feed back of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming components of the apparatus. The apparatus may use thereceived energy either for consuming or for storing the energy in animplanted energy source or the like. The different parameters discussedabove would thus be used if relevant and needed and then as a tool fordetermining the actual energy balance. However, such parameters may alsobe needed per se for any actions taken internally to specificallyoperate the apparatus.

The internal signal transmitter 1027 and the external signal receiver1004 c may be implemented as separate units using suitable signaltransfer means, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 1027 and the externalsignal receiver 1004 c may be integrated in the implantedenergy-transforming device 1002 and the external energy source 1004 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. In accordance with the presentinvention, such an integrated information feedback and energy systemcomprises an implantable internal energy receiver for receiving wirelessenergy, the energy receiver having an internal first coil and a firstelectronic circuit connected to the first coil, and an external energytransmitter for transmitting wireless energy, the energy transmitterhaving an external second coil and a second electronic circuit connectedto the second coil. The external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver. This system further comprises a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off. Inimplementing this system in the arrangement of FIG. 50, the switch 1026is either separate and controlled by the internal control unit 1015, orintegrated in the internal control unit 1015. It should be understoodthat the switch 1026 should be interpreted in its broadest embodiment.This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.

To conclude, the energy supply arrangement illustrated in FIG. 50 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 1015 of the determinationdevice. A control signal reflecting the required amount of energy isalso created by the internal control unit 1015, and the control signalis transmitted from the internal signal transmitter 1027 to the externalsignal receiver 1004 c. Alternatively, the energy balance can bedetermined by the external control unit 1004 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement results from various sensors. The amount of energyemitted from the external energy source 1004 a can then be regulated bythe external control unit 1004 b, based on the determined energybalance, e.g. in response to the received control signal. This processmay be repeated intermittently at certain intervals during ongoingenergy transfer, or may be executed on a more or less continuous basisduring the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 1004 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics.

This system may also be used to obtain information about the couplingfactors between the coils in a TET system even to calibrate the systemboth to find an optimal place for the external coil in relation to theinternal coil and to optimize energy transfer. Simply comparing in thiscase the amount of energy transferred with the amount of energyreceived. For example if the external coil is moved the coupling factormay vary and correctly displayed movements could cause the external coilto find the optimal place for energy transfer. Preferably, the externalcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.

This coupling factor information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorbetween the first and second coils. The energy transmitter may regulatethe transmitted energy in response to the obtained coupling factor.

With reference to FIG. 51, although wireless transfer of energy foroperating the apparatus has been described above to enable non-invasiveoperation, it will be appreciated that the apparatus can be operatedwith wire bound energy as well. Such an example is shown in FIG. 51,wherein an external switch 1026 is interconnected between the externalenergy source 1004 a and an operation device, such as an electric motor1007 operating the apparatus 10. An external control unit 1004 bcontrols the operation of the external switch 1026 to effect properoperation of the apparatus 10.

FIG. 52 illustrates different embodiments for how received energy can besupplied to and used by the apparatus 10. Similar to the example of FIG.50, an internal energy receiver 1002 receives wireless energy E from anexternal energy source 1004 a which is controlled by a transmissioncontrol unit 1004 b. The internal energy receiver 1002 may comprise aconstant voltage circuit, indicated as a dashed box “constant V” in thefigure, for supplying energy at constant voltage to the apparatus 10.The internal energy receiver 1002 may further comprise a constantcurrent circuit, indicated as a dashed box “constant C” in the figure,for supplying energy at constant current to the apparatus 10.

The apparatus 10 comprises an energy consuming part 10 a, which may be amotor, pump, restriction device, or any other medical appliance thatrequires energy for its electrical operation. The apparatus 10 mayfurther comprise an energy storage device 10 b for storing energysupplied from the internal energy receiver 1002. Thus, the suppliedenergy may be directly consumed by the energy consuming part 10 a, orstored by the energy storage device 10 b, or the supplied energy may bepartly consumed and partly stored. The apparatus 10 may further comprisean energy stabilizing unit 10 c for stabilizing the energy supplied fromthe internal energy receiver 1002. Thus, the energy may be supplied in afluctuating manner such that it may be necessary to stabilize the energybefore consumed or stored.

The energy supplied from the internal energy receiver 1002 may furtherbe accumulated and/or stabilized by a separate energy stabilizing unit1028 located outside the apparatus 10, before being consumed and/orstored by the apparatus 10. Alternatively, the energy stabilizing unit1028 may be integrated in the internal energy receiver 1002. In eithercase, the energy stabilizing unit 1028 may comprise a constant voltagecircuit and/or a constant current circuit.

It should be noted that FIG. 50 and FIG. 52 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional components and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the presentinvention.

FIG. 53 schematically shows an energy balance measuring circuit of oneof the proposed designs of the system for controlling transmission ofwireless energy, or energy balance control system. The circuit has anoutput signal centered on 2.5V and proportionally related to the energyimbalance. The derivative of this signal shows if the value goes up anddown and how fast such a change takes place. If the amount of receivedenergy is lower than the energy used by implanted components of theapparatus, more energy is transferred and thus charged into the energysource. The output signal from the circuit is typically feed to an A/Dconverter and converted into a digital format. The digital informationcan then be sent to the external energy-transmission device allowing itto adjust the level of the transmitted energy. Another possibility is tohave a completely analog system that uses comparators comparing theenergy balance level with certain maximum and minimum thresholds sendinginformation to external energy-transmission device if the balance driftsout of the max/min window.

The schematic FIG. 53 shows a circuit implementation for a system thattransfers energy to the implanted energy components of the apparatus ofthe present invention from outside of the patient's body using inductiveenergy transfer. An inductive energy transfer system typically uses anexternal transmitting coil and an internal receiving coil. The receivingcoil, L1, is included in the schematic FIG. 36; the transmitting partsof the system are excluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 53and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 53 the symbols Y1, Y2, Y3 and so on symbolize test points withinthe circuit. The components in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil L1.Energy to implanted components is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

Those skilled in the art will realize that the above various embodimentsof the system could be combined in many different ways. For example, theelectric switch 1006 of FIG. 36 could be incorporated in any of theembodiments of FIGS. 39-45, the hydraulic valve shifting device 1014 ofFIG. 39 could be incorporated in the embodiment of FIG. 38, and the gearbox 1024 could be incorporated in the embodiment of FIG. 37. Pleaseobserve that the switch simply could mean any electronic circuit orcomponent.

The embodiments described in connection with FIGS. 50, 52 and 53identify a method and a system for controlling transmission of wirelessenergy to implanted energy consuming components of an electricallyoperable apparatus. Such a method and system will be defined in generalterms in the following.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming components of an apparatusas described above. The wireless energy E is transmitted from anexternal energy source located outside the patient and is received by aninternal energy receiver located inside the patient, the internal energyreceiver being connected to the implanted energy consuming components ofthe apparatus for directly or indirectly supplying received energythereto. An energy balance is determined between the energy received bythe internal energy receiver and the energy used for the apparatus. Thetransmission of wireless energy E from the external energy source isthen controlled based on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external energy source to a secondary coil in the internal energyreceiver. A change in the energy balance may be detected to control thetransmission of wireless energy based on the detected energy balancechange. A difference may also be detected between energy received by theinternal energy receiver and energy used for the medical device, tocontrol the transmission of wireless energy based on the detected energydifference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the medical device may beconsumed to operate the medical device, and/or stored in at least oneenergy storage device of the medical device.

When electrical and/or physical parameters of the medical device and/orphysical parameters of the patient are determined, the energy may betransmitted for consumption and storage according to a transmission rateper time unit which is determined based on said parameters. The totalamount of transmitted energy may also be determined based on saidparameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external energy source maybe controlled by applying to the external energy source electricalpulses from a first electric circuit to transmit the wireless energy,the electrical pulses having leading and trailing edges, varying thelengths of first time intervals between successive leading and trailingedges of the electrical pulses and/or the lengths of second timeintervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied.

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external energysource may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

A system comprising an apparatus as described above is thus alsoprovided for controlling transmission of wireless energy supplied toimplanted energy consuming components of the apparatus. In its broadestsense, the system comprises a control device for controlling thetransmission of wireless energy from an energy-transmission device, andan implantable internal energy receiver for receiving the transmittedwireless energy, the internal energy receiver being connected toimplantable energy consuming components of the apparatus for directly orindirectly supplying received energy thereto. The system furthercomprises a determination device adapted to determine an energy balancebetween the energy received by the internal energy receiver and theenergy used for the implantable energy consuming components of theapparatus, wherein the control device controls the transmission ofwireless energy from the external energy-transmission device, based onthe energy balance determined by the determination device.

In one embodiment at least one battery may be a part of or replace theenergy-transforming device 1002 to supply energy to the apparatus 10over a power supply line. In one embodiment the battery is notrechargeable. In an alternative embodiment the battery is rechargeable.The battery supply may of course be placed both remote to andincorporated in the device.

Further, the system may comprise any of the following:

-   -   A primary coil in the external energy source adapted to transmit        the wireless energy inductively to a secondary coil in the        internal energy receiver.    -   The determination device is adapted to detect a change in the        energy balance, and the control device controls the transmission        of wireless energy based on the detected energy balance change    -   The determination device is adapted to detect a difference        between energy received by the internal energy receiver and        energy used for the implantable energy consuming components of        the apparatus, and the control device controls the transmission        of wireless energy based on the detected energy difference.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy balance change implies that the energy        balance is increasing, or vice versa, wherein the        decrease/increase of energy transmission corresponds to a        detected change rate.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy difference implies that the received energy        is greater than the used energy, or vice versa, wherein the        decrease/increase of energy transmission corresponds to the        magnitude of said detected energy difference.    -   The energy used for the apparatus is consumed to operate the        apparatus, and/or stored in at least one energy storage device        of the apparatus.    -   Where electrical and/or physical parameters of the apparatus        and/or physical parameters of the patient are determined, the        energy-transmission device transmits the energy for consumption        and storage according to a transmission rate per time unit which        is determined by the determination device based on said        parameters. The determination device also determines the total        amount of transmitted energy based on said parameters.    -   When a difference is detected between the total amount of energy        received by the internal energy receiver and the total amount of        consumed and/or stored energy, and the detected difference is        related to the integral over time of at least one measured        electrical parameter related to the energy balance, the        determination device determines the integral for a monitored        voltage and/or current related to the energy balance.    -   When the derivative is determined over time of a measured        electrical parameter related to the amount of consumed and/or        stored energy, the determination device determines the        derivative for a monitored voltage and/or current related to the        energy balance.    -   The energy-transmission device comprises a coil placed        externally to the human body, and an electric circuit is        provided to power the external coil with electrical pulses to        transmit the wireless energy. The electrical pulses have leading        and trailing edges, and the electric circuit is adapted to vary        first time intervals between successive leading and trailing        edges and/or second time intervals between successive trailing        and leading edges of the electrical pulses to vary the power of        the transmitted wireless energy. As a result, the energy        receiver receiving the transmitted wireless energy has a varied        power.    -   The electric circuit is adapted to deliver the electrical pulses        to remain unchanged except varying the first and/or second time        intervals.    -   The electric circuit has a time constant and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the coil is varied.    -   The electric circuit is adapted to deliver the electrical pulses        to be varied by only varying the lengths of first time intervals        between successive leading and trailing edges of the electrical        pulses.    -   The electric circuit is adapted to supplying a train of two or        more electrical pulses in a row, said train having a first        electrical pulse at the start of the pulse train and having a        second electrical pulse at the end of the pulse train, and    -   the lengths of the second time intervals between successive        trailing edge of the second electrical pulse in a first pulse        train and leading edge of the first electrical pulse of a second        pulse train are varied by the first electronic circuit.    -   The electric circuit is adapted to provide the electrical pulses        as pulses having a substantially constant height and/or        amplitude and/or intensity and/or voltage and/or current and/or        frequency.    -   The electric circuit has a time constant, and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the first coil are varied.    -   The electric circuit is adapted to provide the electrical pulses        varying the lengths of the first and/or the second time        intervals only within a range that includes the first time        constant or that is located relatively close to the first time        constant, compared to the magnitude of the first time constant.

FIGS. 54-57 show in more detail block diagrams of four different ways ofhydraulically or pneumatically powering an implanted apparatus accordingto the invention.

FIG. 54 shows a system as described above with. The system comprises animplanted apparatus 10 and further a separate regulation reservoir 1013,a one way pump 1009 and an alternate valve 1014.

FIG. 55 shows the apparatus 10 and a fluid reservoir 1013. By moving thewall of the regulation reservoir or changing the size of the same in anyother different way, the adjustment of the apparatus may be performedwithout any valve, just free passage of fluid any time by moving thereservoir wall.

FIG. 56 shows the apparatus 10, a two way pump 1009 and the regulationreservoir 1013.

FIG. 57 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 1013 and a servo reservoir 1050. Theservo reservoir 1050 mechanically controls an implanted apparatus 10 viaa mechanical interconnection 1054. The apparatus has anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 1052 in fluid connection with the apparatus 10. Alternatively,the cavity contains compressible gas, which can be compressed andexpanded under the control of the servo reservoir 1050.

The servo reservoir 1050 can also be part of the apparatus itself.

In one embodiment, the regulation reservoir is placed subcutaneous underthe patient's skin and is operated by pushing the outer surface thereofby means of a finger. This system is illustrated in FIGS. 58 a-c. InFIG. 58 a, a flexible subcutaneous regulation reservoir 1013 is shownconnected to a bulge shaped servo reservoir 1050 by means of a conduit1011. This bellow shaped servo reservoir 1050 is comprised in a flexibleapparatus 10. In the state shown in FIG. 58 a, the servo reservoir 1050contains a minimum of fluid and most fluid is found in the regulationreservoir 1013. Due to the mechanical interconnection between the servoreservoir 1050 and the apparatus 10, the outer shape of the apparatus 10is contracted, i.e., it occupies less than its maximum volume. Thismaximum volume is shown with dashed lines in the figure.

FIG. 58 b shows a state wherein a user, such as the patient in with theapparatus is implanted, presses the regulation reservoir 1013 so thatfluid contained therein is brought to flow through the conduit 1011 andinto the servo reservoir 1050, which, thanks to its bellow shape,expands longitudinally. This expansion in turn expands the apparatus 10so that it occupies its maximum volume, thereby stretching the stomachwall (not shown), which it contacts.

The regulation reservoir 1013 is preferably provided with means 1013 afor keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the apparatus 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 59 and 60 a-c. The block diagramshown in FIG. 59 comprises with a first closed system controlling asecond closed system. The first system comprises a regulation reservoir1013 and a servo reservoir 1050. The servo reservoir 1050 mechanicallycontrols a larger adjustable reservoir 1052 via a mechanicalinterconnection 1054. An implanted apparatus 10 having anexpandable/contactable cavity is in turn controlled by the largeradjustable reservoir 1052 by supply of hydraulic fluid from the largeradjustable reservoir 1052 in fluid connection with the apparatus 10.

An example of this embodiment will now be described with reference toFIG. 60 a-c. Like in the previous embodiment, the regulation reservoiris placed subcutaneous under the patient's skin and is operated bypushing the outer surface thereof by means of a finger. The regulationreservoir 1013 is in fluid connection with a bellow shaped servoreservoir 1050 by means of a conduit 1011. In the first closed system1013, 1011, 1050 shown in FIG. 60 a, the servo reservoir 1050 contains aminimum of fluid and most fluid is found in the regulation reservoir1013.

The servo reservoir 1050 is mechanically connected to a largeradjustable reservoir 1052, in this example also having a bellow shapebut with a larger diameter than the servo reservoir 1050. The largeradjustable reservoir 1052 is in fluid connection with the apparatus 10.This means that when a user pushes the regulation reservoir 1013,thereby displacing fluid from the regulation reservoir 1013 to the servoreservoir 1050, the expansion of the servo reservoir 1050 will displacea larger volume of fluid from the larger adjustable reservoir 1052 tothe apparatus 10. In other words, in this reversed servo, a small volumein the regulation reservoir is compressed with a higher force and thiscreates a movement of a larger total area with less force per area unit.

Like in the previous embodiment described above with reference to FIGS.58 a-c, the regulation reservoir 1013 is preferably provided with means1013 a for keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the apparatus 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

Although the different parts described above have specific placements onthe drawings it should be understood that these placements might vary,depending on the application.

The lubricating fluid used in any of the embodiments herein ispreferably a biocompatible lubricating fluid imitating the synovialfluid of the natural hip joint. According to one embodiment thelubricating fluid is Hyaluronic acid.

In all of the embodiments above it is conceivable that the conduit isexcluded and that the channel or channels are in direct connection withthe reservoir or the injection port. Please note that any embodiment orpart of embodiment as well as any method or part of method could becombined in any way. All examples herein should be seen as part of thegeneral description and therefore possible to combine in any way ingeneral terms. Please note that the description in general should beseen as describing both of an apparatus and a method.

The various aforementioned features of the invention may be combined inany way if such combination is not clearly contradictory. The inventionwill now be described in more detail in respect of preferred embodimentsand in reference to the accompanying drawings. Again, individualfeatures of the various embodiments may be combined or exchanged unlesssuch combination or exchange is clearly contradictory to the overallfunction of the device.

The invention claimed is:
 1. An implantable lubrication device forlubricating a joint of a human or mammal patient by adding andcirculating lubricating fluid, the lubrication device comprising: arefillable reservoir comprising a chamber with an adjustable volumeadapted to store a lubricating fluid, and an implantable refillinjection port connected to said refillable reservoir for refilling saidrefillable reservoir with said lubricating fluid, a fluid connectiondevice comprising: a first fluid connection, wherein said first fluidconnection is: a. connected to said reservoir, b. adapted to extendthrough tissue of the patient, and c. in connection with the joint whenimplanted, for introducing said lubricating fluid into said joint whenthe lubrication device is implanted in the patient's body, and a secondfluid connection, wherein said second fluid connection is: a. connectedto said reservoir, b. adapted to extend through tissue of the patient,and c. in connection with the joint when implanted, for returning saidlubricating fluid from said joint to said refillable reservoir when thelubrication device is implanted in the patient's body, and animplantable energized lubrication fluid pump placed along said firstfluid connection for pumping fluid from the refillable reservoir to thejoint and thereby establishing a circulating lubricating fluid flow viasaid joint.
 2. The implantable lubrication device according to claim 1,wherein the lubrication device is adapted to be entirely implantable inthe patient's body.
 3. The implantable lubrication device according toclaim 1, wherein said fluid connection comprises an infusion memberconnected with said fluid connection device, said infusion member beingadapted to be introduced into said joint for injecting said lubricatingfluid into said joint.
 4. The implantable lubrication device accordingto claim 3, wherein said infusion member comprises an infusion needleadapted to be intermittently placed into said joint for injecting saidlubricating fluid into said joint.
 5. The implantable lubrication deviceaccording to claim 3, wherein said infusion member comprises a tubeadapted to be permanently placed into said joint for continuouslyinjecting said lubricating fluid into said joint.
 6. The implantablelubrication device according to claim 3, wherein said infusion member isadapted to intermittently or continuously inject said lubricating fluidinto said joint.
 7. The implantable lubrication device according toclaim 1, comprising a motor connected to said first fluid connectiondevice, said motor being adapted to establish said lubricating fluidflow within said fluid connection device into said joint.
 8. Theimplantable lubrication device according to claim 1, wherein saidreservoir is adapted to change its volume to establish said lubricatingfluid flow into said joint.
 9. The implantable lubrication deviceaccording to claim 8, wherein said reservoir comprises a flexible outerwall for changing the volume of said reservoir to establish saidlubricating fluid flow into said joint.
 10. The implantable lubricationdevice according to claim 8, wherein said reservoir comprises a gaschamber adapted to act as a spring for changing the volume of saidreservoir to establish said lubricating fluid flow into said joint. 11.The implantable lubrication device according to claim 1, wherein saidrefill injection port comprises a self-sealing penetratable membrane.12. The implantable lubrication device according to claim 1, whereinsaid fluid connection device is adapted to establish a continuously orintermittently circulating circular lubricating fluid flow within saidlubrication device.
 13. The implantable lubrication device according toclaim 1, wherein said energized lubrication fluid pump is adapted toincrease the pressure of said lubricating fluid.
 14. The implantablelubrication device according to claim 1, wherein said fluid connectiondevice further comprises at least one of: a filtering device comprisinga filter adapted to remove impurities from said circulating lubricatingfluid flow, a filtering device comprising a filter adapted to removeimpurities from said circulating lubricating fluid flow and a cleaningdevice adapted to clean said filter, a filtering device comprising afilter adapted to remove impurities from said circulating lubricatingfluid flow and a sealed deposition space wherein said filtering deviceis adapted to deposit removed impurities in said sealed depositionspace, and a filtering device comprising a filter adapted to removeimpurities from said circulating lubricating fluid flow and means forreturning said removed impurities back to the patient's body.
 15. Theimplantable lubrication device according to claim 1, wherein saidimplantable lubrication device is adapted to lubricate the joint usinghyaluronic acid.
 16. The implantable lubrication device according toclaim 1, wherein: said reservoir is adapted to be pre-loaded withpressurized lubrication fluid by injections in said refill injectionport, and said refill injection port comprises a self-sealingpenetratable membrane.
 17. The implantable lubrication device accordingto claim 1, further comprising a valve adapted to close the connectionbetween said reservoir and the joint.
 18. The implantable lubricationdevice according to claim 1, wherein said implantable lubrication devicefurther comprises at least one artificial contacting surface, beingimplanted in the joint of the human or mammal body, replacing at leastthe surface of at least one of at least two normal joint contactingsurfaces of the human or mammal patient and carrying weight in thejoint, said artificial contacting surface comprises at least one surfaceoutlet, wherein said artificial contacting surface is adapted todistribute said lubricating fluid from said fluid connection to saidoutlet to lubricate the at least one artificial contacting surface. 19.The implantable lubrication device according to claim 1, wherein saidreservoir is adapted to be at least one of: a. placed at least partlyinside of a bone of the patient, b. placed at least partly inside of thefemoral bone of the patient, c. placed at least partly inside of thepelvic bone of the patient, d. placed at least partly inside of thecollum femur of the patient, e. placed in the abdomen of the patient, f.placed subcutaneously in the body of the patient, g. placed in a cavityin the body of the patient, in a region selected from a group consistingof: i. the abdominal region, ii. the inguinal region, iii. the pelvicregion, and iv. the thigh region.
 20. The implantable lubrication deviceaccording to claim 1, wherein said refill injection port is adapted tobe implanted subcutaneously or in connection with bone.
 21. Theimplantable lubrication device according to claim 1, comprising a systemfor manually and non-invasively controlling the implantable lubricationdevice, comprising at least one of at least one switch implantable inthe patient, a wireless remote control, and an implantable hydraulicreservoir which is hydraulically connected to the implantablelubrication device and adapted to be regulated by manually pressing thehydraulic reservoir.
 22. The implantable lubrication device according toclaim 1, comprising a system comprising at least one of; an internalenergy source for powering implantable energy consuming components ofthe implantable lubrication device, and an internal energy receiver, andan adaptation to be energized non-invasively and wirelessly by an energytransmission device from outside the patient's body, adapted for sendingwireless energy to at least one of: an implantable internal energysource comprised in the system, being chargeable by the energytransferred from the energy transmission device, and at least oneimplantable energy consuming component of the system being energizedwith the wireless energy.
 23. The implantable lubrication deviceaccording to claim 1, comprising a system further comprising a sensorand/or a measuring device sensing or measuring at least one of; at leastone physical parameter of the patient, and at least one functionalparameter related to the implantable lubrication device, comprising atleast one of; a functional parameter correlated to the transfer ofenergy for charging the internal energy source, and a functionalparameter related to the implantable lubrication device, wherein theimplantable lubrication device further comprising a feedback device forsending feedback information from inside the patient's body to at leastone of; an implantable internal control unit comprised, an externalcontrol unit outside of the patient's body, and an external control unitoutside of the patient's body, via the internal control unit, anexternal control unit outside of the patient's body, via the internalcontrol unit according to the programming of the internal control unitperformed by the external control unit, wherein the feedback informationbeing related to at least one of the at least one physical parameter ofthe patient and the at least one functional parameter related to theimplantable lubrication device.